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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

ID3 Medical

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Detailed Description

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical settings post CE-c...

Eligibility Criteria

Inclusion

  • General inclusion criteria
  • 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)
  • Angiographic inclusion criteria:
  • 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
  • Unilateral Common Iliac Artery occlusion
  • Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
  • Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
  • o Type C lesions
  • Bilateral Common Iliac Artery occlusions
  • Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
  • o Type D lesions
  • Unilateral occlusions of both Common Iliac and External Iliac Artery
  • Diffuse disease involving the aorta bifurcation
  • Bilateral occlusions of External Iliac Artery
  • Exclusion Criteria:
  • 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
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
  • Patients with a history of prior life-threatening contrast medium reaction
  • Patients with uncorrected bleeding disorders
  • Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
  • Life expectancy of less than twelve months
  • Any planned surgical intervention/procedure within 30 days of the study procedure
  • Any patient considered to be hemodynamically unstable at onset of procedure
  • Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
  • The target lesion is either a modified TASC-II class B, C or D lesion with aortic or common femoral lesion involvement:
  • o Type B lesions
  • Short (≤3 cm) stenosis of infrarenal aorta
  • o Type C lesions
  • Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery
  • Unilateral External Iliac Artery occlusion that involves the origins of the Internal Iliac and/or Common Femoral Artery
  • Heavily calcified unilateral External Iliac Artery occlusion with or without involvement of origins of the Internal Iliac and/or Common Femoral Artery
  • o Type D lesions
  • Infra-renal aortoiliac occlusion
  • Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
  • Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery

Exclusion

    Key Trial Info

    Start Date :

    November 29 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2025

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT03286361

    Start Date

    November 29 2017

    End Date

    April 1 2025

    Last Update

    October 16 2024

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    O.L.V. Hospital

    Aalst, Belgium, 9300

    2

    ZNA

    Antwerp, Belgium

    3

    Imelda Hospital

    Bonheiden, Belgium, 2820

    4

    A.Z. Sint-Blasius

    Dendermonde, Belgium, 9200