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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02924857




Registration number
NCT02924857
Ethics application status
Date submitted
3/10/2016
Date registered
5/10/2016
Date last updated
11/09/2018

Titles & IDs
Public title
The Chocolate Touch Study
Scientific title
A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
Secondary ID [1] 0 0
CLP788
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermittent Claudication 0 0
Ischemia 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 - Chocolate Touch
Treatment: Devices - Lutonix Drug Coated Balloon

Experimental: Test Group (Chocolate Touch) - The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1.
The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome.
If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.

Active Comparator: Control Group (Lutonix Drug Coated Balloon) - Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion.
The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1).
If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit.
Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.


Treatment: Devices: Chocolate Touch
The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 18 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.

Treatment: Devices: Lutonix Drug Coated Balloon
The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (= 18 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.

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

Outcomes
Primary outcome [1] 0 0
True Drug Coated Balloon Success - A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio <2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Freedom from Major Adverse Events - Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
By Angiographic Core Lab Review (Acute) - Procedural Success: Defined as the success of the therapy to achieve <30% diameter stenosis without a flow-limiting dissection or the need for a stent
Timepoint [1] 0 0
1 hour
Secondary outcome [2] 0 0
By Duplex Ultrasound Core Lab Review - Patency
Timepoint [2] 0 0
6, 12 & 24 months
Secondary outcome [3] 0 0
By Clinical Assessment - Occurrence of relevant Adverse Events
Timepoint [3] 0 0
1, 6, 12, & 24 months

Eligibility
Key inclusion criteria
1. Minimum of 18 years of age

2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)

3. Life Expectancy >2 years

4. Patient has agreed to follow-up requirements and given informed consent

5. Lesion successfully crossed with a guidewire

6. Lesion in the superficial femoral or popliteal artery

7. Target lesion >70% stenosis

8. Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate
Touch to be used 1.1:1 at Target Lesion

9. Target Lesion <18cm that consists of no more than two adjacent lesions (<25mm apart)
and is able to be completely covered with inflation of no more than two assigned
balloons

10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial
vessel without evidence of significant (>70%) stenosis from origin to to ankle

11. In-flow vessel without significant stenosis (<70%) or successful treatment (<30%
residual stenosis with no complications) of a diseased iliac vessel
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute limb ischemia, or patient indicated for thrombolytic therapy

2. Planned surgery within 30 days including interventions on the non-target limb

3. Target Limb concurrent interventions involving a re-entry device, atherectomy, laser,
or ablation procedures, the use of a drug eluting stent, or, treatment with any other
drug coated balloon

4. Myocardial infarction or stroke within 30 days prior to the procedure

5. Known intolerance to required medications, contrast media, nitinol, or Paclitaxel

6. Known impaired Renal Function that could have an impact on contrast tolerance with
Glomerular filtration rate (GFR) = 30 ml/min per 1.73 m^2 and/or elevated serum
creatinine >2.5mg/dL (220µmol/L)

7. Known bleeding disorder or uncontrolled hypercoagulable disorder

8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)

9. Female who is pregnant or intends to be pregnant during study

10. Patient is enrolled in another clinical study or was previously enrolled in this study

11. Presence of perforation, dissection or other injury at access site or in target vessel
at time of enrollment

12. Severe Calcification at the target lesion (defined as angiographic evidence of dense
calcification present on both sides of the vessel wall on two orthogonal views and
that extends >5 continuous cm in length)

13. Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit
crossing by the treatment balloon within the introducer sheath

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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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 outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Vienna
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Krozingen
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
New Zealand
State/province [20] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
TriReme Medical, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study,
designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in
superficial femoral or popliteal arteries with the intention of obtaining regulatory approval
to market this device in the United States
Trial website
https://clinicaltrials.gov/show/NCT02924857
Trial related presentations / publications
Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. Epub 2004 Jul 19.
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24.
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.
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.
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13.
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. Erratum in: Circulation. 2008 Oct 14;118(16):e670.
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Bräunlich S, Ick H, Schuster J, Botsios S, Kruse HJ, Varcoe RL, Scheinert D. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011 Sep 6;58(11):1105-9. doi: 10.1016/j.jacc.2011.05.034.
Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hänninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B. Paclitaxel-coated balloons - Survey of preclinical data. Minerva Cardioangiol. 2010 Oct;58(5):567-82. Review.
Schnorr B, Speck U, Scheller B. Review of clinical data with Paccocath- coated balloon catheters. Minerva Cardioangiol. 2011 Oct;59(5):431-45. Review.
Zeller T, Schmitmeier S, Tepe G, Rastan A. Drug-coated balloons in the lower limb. J Cardiovasc Surg (Torino). 2011 Apr;52(2):235-43. Review.
Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat. 1995 Nov;5(3):297-306.
Public notes

Contacts
Principal investigator
Name 0 0
Mehdi Shishehbor, DO
Address 0 0
Cleveland Medical Center, Cleveland, Ohio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kristine Orosz, BS
Address 0 0
Country 0 0
Phone 0 0
925-931-1300
Fax 0 0
Email 0 0
korosz@trirememedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02924857