Clinical trial NCT05459818: Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
Official title: Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface (VSX) for Peripheral Arterial Disease (INSIGHT VSX)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Vascular Diseases
Keywords: peripheral artarial disease
endovascular treatment
endoprosthesis
Viabahn
Individual patient data analysis
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Primary patency
timeFrame: at 12 months.
Secondary outcomes:
measure: Primary patency
timeFrame: at 24 months
measure: Primary assisted patency
timeFrame: 12 and 24 months
measure: Secondary patency
timeFrame: 12 and 24 months
measure: Freedom from Target Lesion Revascularization (TLR)
timeFrame: 12 and 24 months
measure: Clinical Improvement
timeFrame: 12 and 24 months
measure: Major amputation
timeFrame: 12 and 24 months
measure: Mortality
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
Study officials:
affiliation: Rijnstate
name: MMPJ Reijnen, Prof
role: PRINCIPAL_INVESTIGATOR
References: