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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

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Registry
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Vascular Disease focused on measuring Stenosis (> 75%) or occlusion of the superficial femoral artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smart Stent in the Superficial Femoral Artery .

Arm Description

Outcomes

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.

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)
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
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.
Limbs-salvage rate
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.

Full Information

First Posted
July 3, 2007
Last Updated
March 13, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00496041
Brief Title
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
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 2007 (Actual)
Primary Completion Date
December 31, 2008 (Actual)
Study Completion Date
December 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Stenosis (> 75%) or occlusion of the superficial femoral artery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart Stent in the Superficial Femoral Artery .
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Registry
Intervention Description
A Registry will be used.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Limbs-salvage rate
Time Frame
1 year
Title
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Vermassen, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

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