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Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System

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ClinicalTrials.gov Identifier: NCT02211716
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

Brief Summary:
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System (Bentley InnoMed) in clincial settings post CE-certification when used according to the indications of the IFU.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: BeGraft Peripheral Stent Graft System Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician-Initiated PMCF Trial Investigating the BeGraft Peripheral Stent Graft System for the Treatment of Iliac Lesions
Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: BeGraft
Patient's treated with the BeGraft PMCF Stent Graft System from Bentley Innomed for the treatment of iliac lesions.
Device: BeGraft Peripheral Stent Graft System



Primary Outcome Measures :
  1. Primary patency at 12 months [ Time Frame: 12 months ]
    Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.


Secondary Outcome Measures :
  1. Primary patency rate at 1- and 6-month follow-up [ Time Frame: 1 and 6 months ]
    Patients that present wihout a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without prior TLR.

  2. Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up [ Time Frame: 1 day post-op, 1, 6 and 12 months ]
    The ratio of patients where the implanted stent graft has been occluded.

  3. Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]
    The ABI measurement at 1, 6 and 12 months compared to the baseline ABI measurement.

  4. Performance success rate at baseline [ Time Frame: 1 day post-op ]

    Defined as a composite of:

    • successful in sealing acute perforation or rupture
    • successful in treating aneurysms and fistulae
    • restoration of blood flow

  5. In-stent restenosis rate at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]
    The ratio of patients experiencing in-stent restenosis at the different follow-ups.

  6. Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months [ Time Frame: 1, 6 and 12 months ]
    Defined as freedom from a repeat intervention to maintain or re-estabish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.

  7. Serious Adverse Avents [ Time Frame: up to 12 months ]
  8. Technical success [ Time Frame: 1 day post-op ]
    Defined as the ability to achieve final residual angiographic stenosis no greater than 30%.

  9. Amputation rate at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]
    Defined as any amputation above the knee.

  10. Clinical success at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]
    Defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. General Inclusion criteria

    • Corresponding to the 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 Stent Graft System (Bentley InnoMed)
  2. Angiographic Inclusion Criteria

    • The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:

      • Type A lesions

        • Unilateral or bilateral stenoses of the Common Iliac Artery
        • Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
      • 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
      • Type C lesions

        • Bilateral Common Iliac Artery occlusions
        • Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
      • Type D lesions

        • Unilateral occlusions of both Common Iliac and External Iliac Artery
        • Diffuse disease involving the aorta and both iliac arteries requiring treatment
        • Bilateral occlusions of External Iliac Artery
    • 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 an Deep Femoral 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 collateral(s)
  • Lesions in locations subject to external compression
  • Heavily calcified lesions resistant to 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 PTFE
  • The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:

    • Type B lesions

      • Short (≤3 cm) stenosis of infrarenal aorta
    • 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
    • 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
  • 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, 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
  • Perforation at the angioplasty site evidenced by extravasation of contrast medium
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211716


Locations
Belgium
OLV Hospital
Aalst, Belgium, 9300
Imelda Hospital
Bonheiden, Belgium, 2820
AZ Sint-Blasius
Dendermonde, Belgium, 9200
RZ Heilig Hart Tienen
Tienen, Belgium, 3300
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
Principal Investigator: Koen Deloose, MD Flanders Medical Research Program

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT02211716     History of Changes
Other Study ID Numbers: FMRP-131216
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases