Atherosclerosis Peripheral arterial disease.
Conditions
Interventions
In patients who meet the inclusion criteria (and don't have any exclusion
criterium) Tack-rings will be placed in the SFA with use of the Tack-IT
Endovascular Stapler. A maximum of 8 Tack-rings will
Sponsors
Intact Vascular
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: Age >18 years. Rutherford classification 2, 3 or 4 concerning peripheral arterial disease. ABI 70% Total length of the SFA obstruction
Exclusion criteria
Exclusion criteria: Rutherford classification 5 or 6. Former treatment of the SFA. Former femoro-popliteal bypass. Planned amputation of the ipsilateral leg. Infection of the ipsilateral leg. Significant obstruction of the inflow or outflow arteries of the ipsilateral leg without treatment. Acute thrombosis Immune compromised patient Know coagulopathy, thrombocytopenia, INR > 1.5 Myocardial infarction 30 days prior to treatment Stroke 3 months prior to treatment Renal insufficiency (kreat >220 umo/l) Pregnancy or breast feeding Number of needed Tacks will be >8 Severe, circumferential calcification of the target lesion >5 cm. Subject requires treatment of tibial or outflow vessels at the index procedure. Subject has a known hypersensitivity or contraindication to nitinol. Subject to return for 24 Month Visit has been previously reported as having a non-patent target lesion or a target lesion revascularization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of need for target lesion revascularization during 30 days follow-up. Absence of distal trombo-emblization during 30 days follow-up. Technical success: | — |
Secondary
| Measure | Time frame |
|---|---|
| Amputation free survival at 12 and 24 months follow-up. Freedom from restenosis (>50%) at 12 and 24 months follow-up Changes in ankle brachial index from baseline at 12 and 24 month follow-up. Changes in Rutherford class from baseline at 12 and 24months follow-up. All cause mortality at 12 and 24 months follow-up. | — |
Countries
Netherlands
Outcome results
None listed