NCT01154751

Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Supera Treatment Registry Observing Neointimal Growth

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.

Detailed description

This registry follows up to 200 patients for at least 5 years. The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

Conditions

• Peripheral Artery Disease
• Femoropopliteal Artery Stenosis
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	SUPERA Interwoven self-expanding nitinol stent	Insertion of stent at stenotic area

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-08-01
• Completion: 2015-08-01
• First posted: 2010-07-01
• Last updated: 2017-09-19
• Results posted: 2017-08-17

Locations

4 sites across 1 country: Germany