Peripheral Vascular Disease
Conditions
Brief summary
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).
Detailed description
Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).
Interventions
DEVICETack-It Endovascular Stapler
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
* Rutherford clinical category 2, 3 or 4 * ABI less than or equal to 0.90 * Reference vessel diameter is between 2.5mm and 5.5mm * Target lesion has stenosis greater than or equal to 70% or is occluded * Target lesion is less than or equal to 10cm in length
Exclusion criteria
* Previously implanted stent in the ipsilateral superficial femoral or popliteal artery * Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 30 days | Composite of new-onset major device-related adverse events. |
Countries
Belgium
Outcome results
None listed