Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-Classification

This study is currently recruiting participants.

Verified by University Hospital, Ghent, December 2007

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00496041

Purpose

This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.

Condition	Intervention
Peripheral Vascular Disease	Procedure: Registry

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-Classification

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control. [ Time Frame: 1 year ]

Secondary Outcome Measures:

Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate) [ Time Frame: 1 year ]
Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion [ Time Frame: 1 year ]
Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA. [ Time Frame: 1 year ]
Limbs-salvage rate [ Time Frame: 1 year ]
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class. [ Time Frame: 1 year ]

Estimated Enrollment:

200

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
New TASC (2007) A, B, or C lesions
Vessel diameter between 4.5 and 6.5 cm
Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
At least 1 outflow vessel down to the ankle
Signed informed consent
> Age 50, life expectancy > 1 year
Capable of concluding the necessary follow-up visits

Exclusion Criteria:

Refusal to participate in the study
Acute ischemia
Inflow lesions > 50%, not successfully corrected before the procedure
Combination with other treatment with the exception of treatment to improve the inflow

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496041

Contacts

Contact: Frank Vermassen, MD, PhD

frank.vermassen@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Frank Vermassen, MD, PhD frank.vermassen@ugent.be
Principal Investigator: Frank Vermassen, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Frank Vermassen, MD, PhD

University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2007/208
Study First Received:	July 3, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00496041
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

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

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Constriction, Pathologic

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009