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

NCT03286361 | Active Not Recruiting

• 1 other identifier: ID3-20170711
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary patency at 12 months

  Freedom from \>50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no target lesion revascularization within 12 months.

  12 months

• Periprocedural Serious Adverse Events (SAEs)

  Periprocedural SAEs up to 30-days post-procedure, as defined according to the International Organization of Standardization (ISO) guidelines: ISO 14155:2011

  30-days post-procedure

Secondary Outcomes (8)

• Primary patency rate

  1-, 6-, 24- and 36-months post-procedure

• Stent graft occlusion rate

  Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up

• Ankle-brachial index (ABI)

  1-, 6-, 12-, 24-, and 36-month follow-up

• Amputation rate

  1-, 6-, 12-, 24-, and 36-month follow-up

• Performance success rate

  Baseline

Study Arms (1)

BeGraft Peripheral + Stent Graft System

EXPERIMENTAL

Patients treated with the BeGraft Peripheral Plus Stent Graft System

Device: BeGraft Peripheral Plus Stent Graft System

Interventions

BeGraft Peripheral Plus Stent Graft System DEVICE

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

BeGraft Peripheral + Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Corresponding to the Conformité Européenne (CE)-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
• Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
• Patient is \>18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient is eligible for treatment with the BeGraft Peripheral Plus Stent Graft System (Bentley)
• Patient is treated as emergency case (ruptures, perforations, aneurysms and fistulae)
• The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
• There is angiographic evidence of a patent Common and Deep Femoral Artery
• The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
• o Type A lesions
• Unilateral or bilateral stenosis of the Common Iliac Artery
• Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
• o Type B lesions

You may not qualify if:

• PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
• Presence of an aneurysm immediately adjacent to the site of stent implantation
• Stenosis distal to the site of stent implantation
• Lesions in or adjacent to essential collaterals(s)
• Lesions in locations subject to external compression
• Heavily calcified lesions resistant to percutaneous transluminal angioplasty (PTA)
• Patients with diffuse distal disease resulting in poor stent outflow
• Patients with a history of coagulation disorders
• Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
• Fresh thrombus formation
• Patients with known hypersensitivity to the stent material (L605) and or polytetrafluoroethylene (PTFE)
• Previously implanted stent(s) at the same lesion site
• Reference segment diameter is not suitable for the available stent design
• Untreatable lesion located at the distal outflow arteries
• Use of alternative therapy (e.g. atherectomy, cutting balloon, drug-coated balloon (DCB), laser, radiation therapy) as part of the index procedure

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (9)

O.L.V. Hospital

Aalst, 9300, Belgium

Location

ZNA

Antwerp, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

ZOL

Genk, Belgium

Location

az Groeninge

Kortrijk, Belgium

Location

RZ Heilig Hart

Tienen, Belgium

Location

AZ Jan Portaels

Vilvoorde, Belgium

Location

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  ID3 Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: November 29, 2017
• Primary Completion: April 24, 2023
• Study Completion: April 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8); FR (1)