Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT01499342
• Lead Sponsor: be Medical

Brief Summary

This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

• Signed informed consent
• Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
• TASC II (2007)type A, B or C lesions
• Target vessel diameter between 4.5 and 7 mm
• Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
• At least 1 outflow vessel down to the ankle
• Patient is at least 18 years old
• Life expectancy > 2 years
• Patient is compliant with the requested follow-up visits

Exclusion Criteria

• No informed consent
• Rutherford 6
• TASC II type D lesions
• Patient is not 18 years old
• Patient is pregnant
• Acute ischemia
• Patient is not compliant with the requested follow-up visits
• Unable to cross target lesion with guidewire
• Patient is allergic to nickel-titanium
• Presence of an aneurysm in the SFA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency	12, 24 months	Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as \<50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Secondary patency	12 and 24 months	Patency as defined by absence of \>50% restenosis , whether or not after additional intervention to maintain this patency
Target lesion revascularization	12 and 24 months	Target lesion revascularisation rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or thrombosis at the level of the stented lesion
Target vessel revascularization	12 and 24 months	Target vessel revascularization rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or a new stenosis in the SFA
Limb-salvage rate	12 and 24 months
Clinical success rate	12 and 24 months	Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class.

Trial Locations

Locations (2)

University Hospital Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Limburg, Belgium