Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease

Peripheral Vascular Diseases Clinical Trial

— Insight-VSX  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05459818
• Other study ID #: 2022-2052
• Status: Enrolling by invitation
• Start date: October 12, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 24 months
Secondary	Primary assisted patency	Primary assisted patency is defined as flow through the treated lesion with or without repeat percutaneous intervention completed prior to complete vessel occlusion.	12 and 24 months
Secondary	Secondary patency	Secondary patency is defined as patency in the target lesion maintained by repeat intervention after complete occlusion of the treated arterial segment.	12 and 24 months
Secondary	Freedom from Target Lesion Revascularization (TLR)	Freedom from revascularization of the treated lesion after either restenosis or occlusion by means of a percutaneous vascular intervention, surgical by-pass, thrombolysis, or other such invasive means.	12 and 24 months
Secondary	Clinical Improvement	Clinical improvement is defined as at least one-group improvement in Rutherford Classification compared to baseline.	12 and 24 months
Secondary	Major amputation	Surgical removal of a portion of the study limb (generally above the ankle, transmetatarsal, or metatarsal)	12 and 24 months
Secondary	Mortality	Death, overall and procedure-related (until 30 days)	12 and 24 months