NL-OMON43996
Completed
Not Applicable
Tack Optimized Balloon Angioplasty Study for the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System. (TOBA II) - The TOBA II study
Intact Vascular0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- atherosclerosis
- Sponsor
- Intact Vascular
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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