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 January 2013 by University Hospital, Ghent

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00496041

First received: July 3, 2007

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 3, 2007

Last Updated Date

January 29, 2013

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00496041 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Limbs-salvage rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Peripheral Vascular Disease

Intervention ^ICMJE

Procedure: Registry

A Registry will be used.

Study Arm (s)

Experimental: Smart Stent in the Superficial Femoral Artery .

Intervention: Procedure: Registry

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frank Vermassen, MD, PhD

frank.vermassen@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00496041

Other Study ID Numbers ^ICMJE

2007/208

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frank Vermassen, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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