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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014