Tack Optimized Balloon Angioplasty Study for the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System. (TOBA II)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

CLINICAL INCLUSION CRITERIA;1. * 18 years
3. Target limb requires no additional treatment aside from the target lesion and ipsilateral iliac artery
6. Rutherford Classification 2, 3 or 4
8. Eligible for standard surgical repair, if necessary
9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable);ANGIOGRAPHIC INCLUSION CRITERIA;1. Reference vessel diameter is between 2.5 mm and 6.0 mm, inclusive (by visual estimate)
2. Ability to cross a guidewire (antegrade) through target lesion
3. Has a de novo or non-stented restenotic target lesion indicated for PTA treatment with a
standard or FDA-approved Lutonix drug-coated balloon catheter that meets the following
criteria below:
a. 70% to 99% stenosis with a total lesion length of *20mm and *150mm in length (by visual estimate) or
b.100% occluded with a total lesion length *100mm (by visual estimate)
c. A non-stented restenotic lesion must meet the following criteria:
i. Meets criteria 3a and 3b
ii. No part of the target lesion has been previously treated with a drugcoated
balloon
iii. No part of the target lesion has had more than 2 previous PTA failures
iv. >90 days from most recent angioplasty treatment
4.Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee joint) defined as: located *1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal (P1) artery at the superior end of the patella

Exclusion Criteria

CLINICAL EXCLUSION CRITERIA;1. Rutherford Classification 0, 1, 5 or 6
2. Is pregnant or refuses to use contraception through the duration of the study
3. Previous infrainguinal bypass graft in the target limb
8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
9. Any other previous or planned surgical or endovascular procedure (not including
diagnostic procedures) within 14 days prior to or 30 days post index procedure
10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
16. Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels.
18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint;ANGIOGRAPHIC EXCLUSION CRITERIA:;1. Retrograde access through target limb
2. Acute vessel occlusion or acute or sub-acute thrombosis in target lesion
3. Subject has significant stenosis (*50% stenosis) or occlusion of ipsilateral inflow iliac artery not successfully treated (<30% residual DS and without complication) prior to PTA of target vessel
4. Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable and/or has circumferential calcification
5. The target lesion shows no dissections after PTA
6. Presence of residual diameter stenosis *30% after PTA (based on visual estimate)
7. Non-target limb requiring any vascular treatment at time of index procedure
8. Previously implanted stent in the target vessel

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>Freedom from the occurrence of any new-onset major adverse event(s) (MAEs)<br /><br>defined as index limb amputation (above the ankle), CEC adjudicated<br /><br>clinically-driven target lesion revascularization (CD-TLR), or all-cause death<br /><br>at 30 days.<br /><br>Efficacy:<br /><br>Primary patency defined as freedom from CEC adjudicated clinically-driven<br /><br>target lesion revascularization (CD-TLR) and freedom from core lab adjudicated<br /><br>duplex ultrasound derived binary restenosis at 12 months (defined as PSVR<br /><br>>2.5).</p><br>

Secondary Outcome Measures