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BeGraft as Bridging Stent in FEVAR Investigating the BeGraft Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT03987035
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education)

Brief Summary:
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft balloon expandable covered stent Graft System (Bentley Innomed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Device: BeGraft Stent Graft System as bridging stent Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician-Initiated Trial Investigating the BeGraft Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BeGraft Stent Graft System
BeGraft Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
Device: BeGraft Stent Graft System as bridging stent
BeGraft Stent Graft System as bridging stent




Primary Outcome Measures :
  1. Efficacy endpoint (1) - Technical success [ Time Frame: 1 day post-op ]
    defined as successfully introduction and deployment of the BeGraft Balloon Expandable covered Stent Graft System

  2. Efficacy endpoint (2) ) Bridging stent patency at 12 months [ Time Frame: 12 months post-op ]
    defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT Angio at 12 months

  3. Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months [ Time Frame: 12 months post-op ]
    Absence of procedure related complications and bridging stent related endoleaks at 12 months


Secondary Outcome Measures :
  1. Bridging stent patency post-op and at 6 months [ Time Frame: 1 day post-op and 6 months post-op ]
    defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio

  2. Freedom from bridging stent related endoleaks post-op and at 6 months [ Time Frame: 1 day post-op and 6 months post-op ]
    Freedom from bridging stent related endoleaks post-op and at 6 months, based on imaging (duplex ultrasound, CT angiography)

  3. Freedom from bridging stent related secondary intervention post-op at 6 and 12 months [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
    Freedom from bridging stent related endoleaks post-op and at 6 and 12 months, based on imaging (duplex ultrasound, CT angiography)

  4. Freedom from type I & III endoleaks post-procedure post-op and at 6 and 12 months [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
    Freedom from type I & III endoleaks post-op and at 6 and 12 months, based on imaging (duplex ultrasound, CT angiography)

  5. 30-day mortality [ Time Frame: 30 days post-op ]
  6. Freedom from stent graft migration post-op and at 6 and 12 [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
    defined as freedom from stent graft migration (more than 10 mm)

  7. Freedom from AAA diameter increase at 6 and 12 months post-op [ Time Frame: 6 and 12 months post-op ]
    defined as more than 5mm increase in maximum diameter measured at 6 and 12 months as compared to post-op implantation, based on imaging (duplex ultrasound or CT Angiography)

  8. Freedom from aneurysm related secondary endovascular procedures post-op and at 6 and 12 months [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
    Freedom from aneurysm related secondary endovascular procedures post-op and at 6 months, based on imaging (duplex ultrasound, CT angiography)

  9. Freedom from conversion to open surgical repair post-procedure and at 6 and 12 months [ Time Frame: 1 day post-op, 6 and 12 months post-op ]
    Freedom from conversion to open surgical repair post-op and at 6 months, based on imaging (duplex ultrasound, CT angiography)

  10. Freedom from aneurysm related mortality post-procedure and at 6 and 12 months [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
  11. Freedom from aneurysm rupture within 12 months post-implantation [ Time Frame: up to 12 months post-op ]
  12. Freedom from any major adverse events post-procedural and at 6 and 12 months [ Time Frame: 1 day post-op and at 6 and 12 months post-op ]
  13. Health Related Quality of Life scores at 12 months post-implantation by using EQ-5D questionnaire [ Time Frame: 12 months post-op ]


Information from the National Library of Medicine

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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:

  • Patient is willing to comply with specified follow-up evaluations at the specified times
  • Patient is ≥18 years old
  • Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
  • Patient has a projected life-expectancy of at least 12-months
  • Indication of elective repair of AAA or TAAA with FEVAR in accordance with the applicable guidelines for vascular interventions
  • Patient needs to have a landing zone in their target vessel of at least 10mm
  • No early important division branch from the target vessel with risk of coverage
  • Absence of dissection

Exclusion Criteria:

  • Previously implanted endograft
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients with uncorrected bleeding disorders or heparin induced thrombozytopenia
  • 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.
  • Sharp downward take off of the target vessel
  • Leaking/ruptured or symptomatic aneurysm
  • Patients with known hypersensitivity to the stent material (L605) and/or PTFE

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): NCT03987035


Contacts
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Contact: Jeroen Wauters +3252252822 jeroen.wauters@fcre.eu

Sponsors and Collaborators
Prof. Giovanni Torsello
Investigators
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Study Director: Giovanni Torsello, Prof. Dr. Foundation for Cardiovascular Research and Education

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Responsible Party: Prof. Giovanni Torsello, Director, FCRE (Foundation for Cardiovascular Research and Education)
ClinicalTrials.gov Identifier: NCT03987035     History of Changes
Other Study ID Numbers: FCRE-190130
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases