A Phase 4 interventional study of ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent in Peripheral Vascular Diseases, sponsored by Abbott Medical Devices. Completed at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-24.
Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).
Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's planned enrollment of 120 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
Exclusion Criteria:
The purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.
Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).
Time frame: At 180 days
Clinically driven target lesion revascularization
Time frame: at 12 and 24 month follow-up
Target lesion primary, primary assisted and secondary patency rates
Time frame: at 6, 12 and 24 month follow-up
Major complications
Time frame: at 1, 6, 12 and 24 month follow-up
Angiographic binary restenosis rate in a subset of patients
Time frame: at 9 month follow-up
Device and procedure success
Time frame: Acute
Vascular and bleeding complications (local and puncture site)
Time frame: 1, 6, 12, 24 months
Stent fracture determined by biplane X-ray
Time frame: at 12 month follow-up
Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound)
Time frame: 365 days and 2 years
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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