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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02942966




Registration number
NCT02942966
Ethics application status
Date submitted
20/10/2016
Date registered
24/10/2016
Date last updated
6/05/2019

Titles & IDs
Public title
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
Scientific title
Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
Secondary ID [1] 0 0
CA 0137
Universal Trial Number (UTN)
Trial acronym
TOBA II BTK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 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 - Tack Endovascular System

Experimental: Tack Implant - Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.


Treatment: Devices: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.

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

Outcomes
Primary outcome [1] 0 0
Efficacy - Freedom from MALE at 6 months - Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Efficacy - Freedom from POD at 30 days - Freedom from perioperative death (POD) at 30 days
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Safety - Freedom from MALE at 30 days - Freedom from major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis)
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
Safety - Freedom from POD at 30 days - Freedom from perioperative death (POD) at 30 days
Timepoint [4] 0 0
30 days
Secondary outcome [1] 0 0
Patency - Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Target Limb Salvage - Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
- Males or non-pregnant females = 18 years of age at the time of consent

- Female subjects of childbearing potential must have a negative pregnancy test prior to
treatment and must use some form of contraception (abstinence is acceptable) through
the duration of the study

- Subject has been informed of and understands the nature of the study and provides
signed informed consent to participate in the study. If the subject possesses the
ability to understand and provide informed consent but due to physical inability, the
subject cannot sign the informed consent form (ICF), an impartial witness may sign on
behalf of the subject

- Willing to comply with all required follow-up visits

- Rutherford Classification 4 or 5.

- WIfI Wound grade of 0, 1 or modified 2.

- WIfI Foot Infection grade of 0 or 1.

- Estimated life expectancy =1 year
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Is pregnant or refuses to use contraception through the duration of the study

- Previous bypass graft in the target limb

- Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the
index procedure

- Prior or planned above-ankle amputation or complete transmetatarsal amputation to the
target limb (this does not apply to ray amputation of =2 digits, simple digital
amputations or ulcer debridements)

- WIfI Foot Infection grade 2 or 3

- Any systemic infection or immunocompromised state. Patients with an ascending
infection/deep foot infection or abscess/white blood count (WBC)=12,000/or febrile
state

- Endovascular or surgical procedure (not including diagnostic procedures, planned
simple digital amputation or wound debridement) to the target limb less than 30 days
prior to or planned for less than 30 days after the index procedure

- Existing stent implant in the target vessel

- Any other endovascular or surgical procedure (not including diagnostic procedures,
planned simple digital amputation or wound debridement) less than 14 days prior to the
index procedure or planned procedure less than 30 days after the index procedure

- Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder,
or a platelet count less than 80,000/microliter or greater than 500,000/microliter

- WIfI Wound grade of 2 or 3.

- Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is
contraindicated

- Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the
Index Procedure

- History of stroke or transient ischemic attack (TIA) less than 90 days prior to the
Index Procedure

- Currently on dialysis

- Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)

- Participating in another ongoing investigational clinical trial in which the subject
has not completed the primary endpoint(s)

- Has other comorbidities that, in the opinion of the investigator, would preclude them
from receiving this treatment and/or participating in study-required follow-up
assessments

- Known hypersensitivity or allergy to contrast agents that cannot be medically managed

- Subject already enrolled into this study

- Restenotic target lesion previously treated by means other than plain balloon
angioplasty and/or less than 1 year prior to index procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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 outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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Iowa
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Louisiana
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Michigan
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Missouri
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New Jersey
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New Mexico
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United States of America
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North Carolina
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Ohio
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Pennsylvania
Country [18] 0 0
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Rhode Island
Country [19] 0 0
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South Carolina
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United States of America
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Tennessee
Country [21] 0 0
United States of America
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Texas
Country [22] 0 0
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Virginia
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United States of America
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Washington
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
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Germany
State/province [26] 0 0
Arnsberg
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Germany
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Berlin
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Germany
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Heide
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Germany
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Leipzig
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Germany
State/province [30] 0 0
Mülheim an der Ruhr
Country [31] 0 0
Germany
State/province [31] 0 0
Nordheide
Country [32] 0 0
Germany
State/province [32] 0 0
Sonneberg
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Kecskemét
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Intact Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate
the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial,
and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post
percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
Trial website
https://clinicaltrials.gov/show/NCT02942966
Trial related presentations / publications
Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review.
Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
Public notes

Contacts
Principal investigator
Name 0 0
Patrick J. Geraghty, MD
Address 0 0
Washington University School of Medicine in St. Louis
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