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Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment

NCT03286361 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-16

No results posted yet for this study

Summary

The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36 month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and 36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

BeGraft Peripheral Plus Stent Graft System

Patients will be treated with the BeGraft Peripheral Plus Stent Graft System

Sponsors & Collaborators

  • ID3 Medical

    lead OTHER

Principal Investigators

  • Koen Deloose, MD · ID3 Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2023-04-24
Completion
2025-04-30

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286361 on ClinicalTrials.gov