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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00496041
First received: July 3, 2007
Last updated: December 4, 2014
Last verified: December 2014
July 3, 2007
December 4, 2014
July 2007
July 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00496041 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Peripheral Vascular Disease
Procedure: Registry
A Registry will be used.
Experimental: Smart Stent in the Superficial Femoral Artery .
Intervention: Procedure: Registry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00496041
2007/208
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Frank Vermassen, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

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