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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
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Estimated Enrollment: 200
Study Start Date: July 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smart Stent in the Superficial Femoral Artery . Procedure: Registry
A Registry will be used.

  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

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

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00496041     History of Changes
Other Study ID Numbers: 2007/208
Study First Received: July 3, 2007
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Stenosis (> 75%) or occlusion of the superficial femoral artery

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 19, 2013