Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease

NCT05459818 | Completed

• 1 other identifier: 2022-2052
• Study Type: observational
• Target: 977
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Vascular Diseases

Keywords

peripheral artarial disease; endovascular treatment; endoprosthesis; Viabahn; Individual patient data analysis

Outcome Measures

Primary Outcomes (1)

• Primary patency

  Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR \< 2.5) or no angiographic evidence of stenosis \> 50% if CDUS is uninterpretable or unavailable.

  at 12 months.

Secondary Outcomes (7)

• Primary patency

  at 24 months

• Primary assisted patency

  12 and 24 months

• Secondary patency

  12 and 24 months

• Freedom from Target Lesion Revascularization (TLR)

  12 and 24 months

• Clinical Improvement

  12 and 24 months

Interventions

Viabahn implanted DEVICE

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.

Also known as: endovascular treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. For this purpose authors are asked to provide extensive patient information (anonymized): patient characteristics at baseline (e.g. comorbidities), lesion details, procedural details, hospitalization details, follow-up visits.

You may qualify if:

• 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.
• Lesions ≥10 cm in length and TASC C or D classification will be included
• Patient-level data can be obtained and pooled with other studies

You may not qualify if:

• Patient was not formally enrolled in their corresponding study (e.g., training cases)
• Patient was enrolled for treatment of in-stent restenotic lesions.
• Patient has incomplete or missing data that does not allow for analysis.
• Case reports (n\<10 patients)

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate

Arnhem, Netherlands

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• MMPJ Reijnen, Prof

  Rijnstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: October 12, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)