Peripheral Arterial Disease Clinical Trial
— BOSSOfficial title:
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
NCT number | NCT01499342 |
Other study ID # | BM/BOSS 02-002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2009 |
Est. completion date | February 2014 |
Verified date | May 2014 |
Source | be Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 435 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost Limburg | Genk | Limburg |
Belgium | University Hospital Leuven | Leuven | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
be Medical | Universitaire Ziekenhuizen Leuven, Ziekenhuis Oost-Limburg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Secondary patency | Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency | 12 and 24 months | |
Secondary | Target lesion revascularization | 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 | 12 and 24 months | |
Secondary | Target vessel revascularization | 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 | 12 and 24 months | |
Secondary | Limb-salvage rate | 12 and 24 months | ||
Secondary | Clinical success rate | Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class. | 12 and 24 months |
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