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

NCT01499342 | Completed

• 1 other identifier: BM/BOSS 02-002
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Keywords

Stent; Atherosclerotic occlusive disease; Peripheral arterial disease; Superficial femoral artery; SFA

Outcome Measures

Primary Outcomes (1)

• Primary patency

  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.

  12, 24 months

Secondary Outcomes (5)

• Secondary patency

  12 and 24 months

• Target lesion revascularization

  12 and 24 months

• Target vessel revascularization

  12 and 24 months

• Limb-salvage rate

  12 and 24 months

• Clinical success rate

  12 and 24 months

Study Arms (1)

Rutherford category 2 - 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stenosis (\> 75%) or occlusion of the superficial femoral artery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• be Medical: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (2)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Location

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Sabrina Houthoofd, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Herman Schroë, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: December 26, 2011
• Study Start: November 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 22, 2022

Record last verified: 2014-05

Locations

BE (2)