Peripheral Arterial Disease
Conditions
Keywords
Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication
Brief summary
This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of \>150mm and ≤250mm.
Interventions
DEVICETack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must meet all of the following inclusion criteria to be eligible for enrollment: 1. Male or non-pregnant Female ≥ 18 years of age at the time of consent 2. 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 3. Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure 4. 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 ICF, an impartial witness may sign on behalf of the subject 5. Willing to comply with all required follow-up visits 6. Rutherford Classification 2, 3 or 4 7. Estimated life expectancy \>1 year 8. Eligible for standard surgical repair, if necessary 9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable
Exclusion criteria
* Subject must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Freedom from the occurrence of any new-onset major adverse event(s) | 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. |
| Efficacy - Primary Patency | 12 months | Primary patency defined as freedom from 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 PSVR \>2.5:1). |
Countries
Austria, Belgium, Germany, Switzerland
Outcome results
None listed