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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

435 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Rutherford category 2 - 5

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No