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

NCT00496041 | Completed

• 1 other identifier: 2007/208
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease

Keywords

Stenosis (> 75%) or occlusion of the superficial femoral artery

Outcome Measures

Primary Outcomes (1)

• Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.

  1 year

Secondary Outcomes (5)

• Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)

  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

  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.

  1 year

• Limbs-salvage rate

  1 year

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

  1 year

Study Arms (1)

Smart Stent in the Superficial Femoral Artery .

EXPERIMENTAL

Procedure: Registry

Interventions

Registry PROCEDURE

A Registry will be used.

Smart Stent in the Superficial Femoral Artery .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Conditions

Peripheral Vascular Diseases; Constriction, Pathologic

Interventions

Registries

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Frank Vermassen, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Primary Completion: December 31, 2008
• Study Completion: December 31, 2008
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

BE (1)