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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03241459




Registration number
NCT03241459
Ethics application status
Date submitted
1/08/2017
Date registered
7/08/2017
Date last updated
6/09/2019

Titles & IDs
Public title
Safety and Efficacy of the SurVeilâ„¢ Drug-Coated Balloon
Scientific title
The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeilâ„¢ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon
Secondary ID [1] 0 0
SUR17-001
Universal Trial Number (UTN)
Trial acronym
TRANSCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Peripheral Vascular Disease 0 0
Artery Disease, Peripheral 0 0
Femoropopliteal Artery Occlusion 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surmodics SurVeil DCB
Treatment: Devices - Medtronic IN.PACT Admiral DCB

Experimental: Surmodics SurVeil DCB - Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.

Active Comparator: Medtronic IN.PACT Admiral DCB -


Treatment: Devices: Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Study is 1:1 randomized against comparator.

Treatment: Devices: Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Study is 1:1 randomized against SurVeil DCB.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Lesion Patency - Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Safety composite of death, amputation, and target vessel revascularization (TVR) - Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Device Success - Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection using only the study device.
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
Technical Success - Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.
Timepoint [2] 0 0
Day 0
Secondary outcome [3] 0 0
Procedure Success - Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.
Timepoint [3] 0 0
72 hours
Secondary outcome [4] 0 0
Clinical Success - Freedom from all-cause death, major target limb amputation and TVR through 30 days
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Primary Lesion Patency - Applicable only if both the primary safety and efficacy hypotheses of noninferiority are met.
Primary patency defined as a composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs).
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Target Vessel Patency - Defined as freedom from clinically-driven TVR and binary restenosis (restenosis defined as DUS PSVR =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs).
Timepoint [6] 0 0
12 months, 24 months
Secondary outcome [7] 0 0
Sustained Clinical Improvement - Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.
Timepoint [7] 0 0
6 months, 12 months, 24 months
Secondary outcome [8] 0 0
Clinically-driven TLR - Clinically-driven target lesion revascularization, within 6, 12, 24, 36, 48, and 60 months
Timepoint [8] 0 0
6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary outcome [9] 0 0
Historical MAEs - Major Adverse Events (MAEs) defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 60 months.
Timepoint [9] 0 0
6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary outcome [10] 0 0
Major amputation - Major target limb amputation, within 6, 12, 24, 36, 48, and 60 months.
Timepoint [10] 0 0
6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary outcome [11] 0 0
Thrombosis - Thrombosis at target limb, within 6, 12, 24, 36, 48, and 60 months.
Timepoint [11] 0 0
6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary outcome [12] 0 0
Rutherford Class - Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months.
Timepoint [12] 0 0
Screening, 1 month, 6 months, 12 months, and 24 months
Secondary outcome [13] 0 0
PARC Class - Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.
Timepoint [13] 0 0
Screening, 1 month, 6 months, 12 months, and 24 months
Secondary outcome [14] 0 0
Ankle Brachial Index (ABI) - Decrease in target limb ABI or toe brachial index =0.15 from baseline to 6, 12, and 24 months.
Timepoint [14] 0 0
Screening, 6 months, 12 months, and 24 months
Secondary outcome [15] 0 0
Walking Impairment Questionnaire (WIQ) - Change in WIQ score from baseline to 1, 12, and 24 months.
Timepoint [15] 0 0
Screening, 1 month, 12 months, and 24 months
Secondary outcome [16] 0 0
Six Minute Walk Test (6MWT) - Change in 6MWT from baseline to 12 and 24 months.
Timepoint [16] 0 0
Screening, 12 months, and 24 months
Secondary outcome [17] 0 0
Peripheral Artery Questionnaire (PAQ) - Change in PAQ score from baseline to 1, 12, and 24 months.
Timepoint [17] 0 0
Screening, 1 month, 12 months, and 24 months

Eligibility
Key inclusion criteria
- Subject is =18 years.

- Subject has target limb Rutherford classification 2, 3 or 4.

- Subject has provided written informed consent and is willing to comply with study
follow-up requirements.

- De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior
plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.

- Target lesion location starts =10 mm below the common femoral bifurcation and
terminates distally at or above the end of the P1 segment of the popliteal artery.

- Target vessel diameter =4 mm and =7 mm.

- Target lesion must have angiographic evidence of =70% stenosis by operator visual
estimate.

- Chronic total occlusions may be included only after successful, uncomplicated wire
crossing of target lesion via an anterograde approach and without the use of
subintimal dissection techniques.

- Target lesion must be =180 mm in length (one long lesion or multiple serial lesions)
by operator visual estimate. Note: combination lesions must have a total lesion length
of =180 mm by visual estimate and be separated by =30 mm.

- Target lesion is located at least 30 mm from any stent, if target vessel was
previously stented.

- Successful, uncomplicated (without use of a crossing device) wire crossing of target
lesion. Successful crossing of the target lesion occurs when the tip of the guide wire
is distal to the target lesion without the occurrence of flow-limiting dissection or
perforation and is judged by visual inspection to be within the true lumen.

- After pre-dilatation, the target lesion is =70% residual stenosis, absence of a flow
limiting dissection and treatable with available device matrix.

- A patent inflow artery free from significant stenosis (=50% stenosis) as confirmed by
angiography.

- At least one patent native outflow artery to the ankle or foot, free from significant
stenosis (=50% stenosis) as confirmed by angiography.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has acute limb ischemia.

- Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using
plain old balloon angioplasty (POBA) or a stent within the previous 90 days.

- Subject underwent any lower extremity percutaneous treatment using a
paclitaxel-eluting stent or a DCB within the previous 90 days.

- Subject underwent PTA of the target lesion using a DCB within the previous 180 days.

- Subject has had prior vascular intervention in the contralateral limb within 14 days
before the planned study index procedure or subject has planned vascular intervention
in the contralateral limb within 30 days after the index procedure.

- Subject is pregnant, breast-feeding or intends to become pregnant during the time of
the study.

- Subject has life expectancy less than 2 years.

- Subject has a known allergy to contrast medium that cannot be adequately
pre-medicated.

- Subject is allergic to ALL antiplatelet treatments.

- Subject has impaired renal function (i.e. serum creatinine level =2.5 mg/dL).

- Subject is dialysis dependent.

- Subject is receiving immunosuppressant therapy.

- Subject has known or suspected active infection at the time of the index procedure.

- Subject has platelet count <100,000/mm3 or >700,000/mm3.

- Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the study procedure.

- Subject is diagnosed with coagulopathy that precludes treatment with systemic
anticoagulation and/or dual antiplatelet therapy (DAPT).

- Subject has history of stroke within the past 90 days.

- Subject has a history of myocardial infarction within the past 30 days.

- Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.

- Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.

- Subject is participating in another investigational drug or medical device study that
has not completed primary endpoint(s) evaluation or that clinically interferes with
the endpoints from this study, or subject is planning to participate in such studies
prior to the completion of this study.

- Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or
intervention unrelated to this study within 30 days prior to the index procedure or
has planned major surgical procedure or intervention within 30 days of the index
procedure.

- Subject had previous bypass surgery of the target lesion.

- Subject had previous treatment of the target vessel with thrombolysis or surgery.

- Subject is unwilling or unable to comply with procedures specified in the protocol or
has difficulty or inability to return for follow-up visits as specified by the
protocol.

- Target lesion has severe calcification (as defined by the PARC classification of
calcification).

- Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).

- Target lesion requires treatment with alternative therapy such as stenting, laser,
atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection
techniques.

- Significant target vessel tortuosity or other parameters prohibiting access to the
target lesion.

- Presence of thrombus in the target vessel.

- Iliac inflow disease requiring treatment, unless the iliac artery disease is
successfully treated first during the index procedure. Success is defined as =30%
residual diameter stenosis without death or major complications.

- Presence of an aortic, iliac or femoral artificial graft.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Trials New Zealand - Hamilton
Recruitment hospital [2] 0 0
Prince of Wales Private Hostpital - Randwick
Recruitment postcode(s) [1] 0 0
- Hamilton
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Austria
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Graz
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Austria
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Vienna
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Belgium
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Aalst
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Belgium
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Dendermonde
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Belgium
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Ghent
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Belgium
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Tienen
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Czechia
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Brno
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Czechia
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Ostrava
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Germany
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Karlsbad
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Sonneberg
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Bergamo
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Italy
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Florence
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Riga
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Auckland
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Singapore
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Switzerland
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Lugano

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SurModics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment
of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral
and/or popliteal arteries.
Trial website
https://clinicaltrials.gov/show/NCT03241459
Trial related presentations / publications
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group, Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. Epub 2006 Nov 29.
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Müller-Hülsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.
Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum in: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.
Public notes

Contacts
Principal investigator
Name 0 0
William Gray, MD
Address 0 0
Lankenau Heart Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications