Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Philips Clinical & Medical Affairs Global
- Enrollment
- 213
- Locations
- 39
- Primary Endpoint
- Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must meet all of the following inclusion criteria to be eligible for enrollment:
- •Male or non-pregnant Female ≥ 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 through the duration of the study (abstinence is acceptable)
- •Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
- •Subject or 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, an impartial witness may sign on behalf of the subject
- •Willing to comply with all required follow-up visits
- •Rutherford Classification 2, 3 or 4
- •Estimated life expectancy \>1 year
- •Eligible for standard surgical repair, if necessary
- •Subject is ambulatory (assistive devices such as a cane or walker is acceptable)
Exclusion Criteria
- •Subject must NOT meet any of the following exclusion criteria to be eligible for enrollment:
- •Rutherford Classification 0, 1, 5 or 6
- •Is pregnant or refuses to use contraception through the duration of the study
- •Previous infrainguinal bypass graft in the target limb
- •Planned amputation on the target limb
- •Systemic infection or Infection within the target limb and/or immunocompromised
- •Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
- •Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
- •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
- •Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
Outcomes
Primary Outcomes
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
Time Frame: 12 Months
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5)
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
Time Frame: 30 Days
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.