Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease

NCT ID: NCT05459818

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 977 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2025-10-01

Brief Summary

To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

Detailed Description

Rationale: Studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (SFA) occlusive disease have mainly focused on stent patency. Subgroup analysis was often not feasible, related to small sample sizes. This pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from VSX treatment. The current analysis will provide insights into the effectiveness of the VSX device for specific subgroups.

Objective: To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

Study design: Multicenter retrospective individual patient data meta-analysis. Study population: Patients treated with a VSX device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective VSX study whom were treated for SFA disease with the latest generation heparin-bonded Viabahn, and published in peer reviewed journals.

Main study parameters/endpoints: The primary study parameter is primary patency at 12-months. In addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from Target Lesion Revascularization (TLR) at 12 and 24 months, clinical Improvement, minor and major amputation, mortality. The following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (Rutherford 4-6), patients with intermittent claudication (Rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, TASC II lesion classification, calcified lesions, by device diameter.

Conditions

Peripheral Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Viabahn implanted

An individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery.

Intervention Type: DEVICE

Other Intervention Names

endovascular treatment

Eligibility Criteria

Inclusion Criteria

1. Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery.

2. Lesions ≥10 cm in length and TASC C or D classification will be included

3. Patient-level data can be obtained and pooled with other studies

Exclusion Criteria

1. Patient was not formally enrolled in their corresponding study (e.g., training cases)

2. Patient was enrolled for treatment of in-stent restenotic lesions.

3. Patient has incomplete or missing data that does not allow for analysis.

4. Case reports (n<10 patients)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MMPJ Reijnen, Prof

Role: PRINCIPAL_INVESTIGATOR

Rijnstate

Locations

Rijnstate

Arnhem, , Netherlands

Countries

Netherlands

Other Identifiers

2022-2052

Identifier Type: -

Identifier Source: org_study_id