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出境医 / 临床实验 / BGP Stent as Bridging Stent in FEVAR
BGP Stent as Bridging Stent in FEVAR
Study Description
Brief Summary:
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) 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 |
|---|---|---|
| Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture Abdominal Aortic Aneurysm, Without Mention of Rupture | Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent | Phase 3 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Application of BeGraft Peripheral Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms |
| Actual Study Start Date : | March 18, 2021 |
| Estimated Primary Completion Date : | July 1, 2022 |
| Estimated Study Completion Date : | July 1, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BGP Stent Graft System
BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
|
Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent
BGP Stent Graft System as bridging stent
|
Outcome Measures
Primary Outcome Measures :
- Efficacy endpoint (1) - Technical success [ Time Frame: 1 day post-op ]Successful introduction and deployment of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley Innomed, Hechingen, Germany) implanted as bridging stent in FEVAR
- 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
- Safety endpoint 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 :
- Bridging stent patency post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Bridging stent patency post-op and at 6-, 12- and 24-months, defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex ultrasound or CT Angio
- Freedom from bridging stent related endoleaks post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from bridging stent related endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)
- Freedom from bridging stent related secondary intervention post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from bridging stent related secondary intervention post-op, 6-, 12- and 24- months
- Freedom from type I & III endoleaks post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from type I & III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography)
- 30-day mortality [ Time Frame: 30 days post-op ]
- Freedom from stent graft migration post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]defined as freedom from stent graft migration (more than 10 mm)
- Freedom from AAA diameter increase [ Time Frame: 6-, 12, and 24- months post-op ]defined as more than 5mm increase in maximum diameter measured at 6- , 12- and 24- months as compared to postop-implantation, based on imaging (duplex ultrasound or CT Angiography)
- Freedom from aneurysm related secondary endovascular procedures post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from aneurysm related secondary endovascular procedures
- Freedom from conversion to open surgical repair post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from conversion to open surgical repair post-op
- Freedom from aneurysm related mortality post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from aneurysm related mortality post-procedure
- Freedom from aneurysm rupture within 12- and 24-months post-implantation [ Time Frame: 12, and 24- months post-op ]Freedom from aneurysm rupture within 12- and 24-months post-implantation
- Freedom from any major adverse events post-procedure [ Time Frame: 1 day post-op, 6-, 12, and 24- months post-op ]Freedom from any major adverse events post-procedure
- Health Related Quality of Life scores [ Time Frame: 12- and 24-months post-op ]Health Related Quality of Life scores at 12- and 24-months post implantation
Eligibility Criteria
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient eligible for elective repair of AAA/TAAA extent IV with FEVAR in accordance with the applicable guidelines for vascular interventions (Aneurysm size 5.5cm or aneurysm growth of >5 mm within 6 months or 1 cm within 1 year).
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >55 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
- Target vessels (renal arteries, superior mesenteric artery and celiac trunk) should have a diameter between 5 and 10 mm
- Patient eligible for fenestrated endovascular repair as per IFU of the fenestrated endograft
- Angulation of the aorta at the level of the target vessels <45 degrees
- The fenestrated endograft has to be constructed so the fenestrations lie in front of the orifice of the target vessel, and the gap between the fenestration and the orifice of the target vessel should not exceed 10mm.
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
- 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.
- Patients with diffuse distal disease resulting in poor stent outflow
- Fresh thrombus formation
- Stenosed (>50%) or occluded target vessel
- Angulation between renal artery and aortic wall <30 degrees
- Patients with known hypersensitivity to the stent material (L605) and/or PTFE
- Hybrid Approach
- Patients with a connective tissue disorder
- Patients with mycotic or inflammatory aneurysm
- Myocardial infarction or stroke within 3 months prior to the procedure
- Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
- Patients with ASA classification 5 or higher
- Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
- Patients with increased risk of intraoperative rupture
- Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath
Contacts and Locations
Contacts
| Contact: Jeroen Wauters | +3252252822 | jeroen.wauters@fcre.eu | |
| Contact: Annelena Held-Wehmöller, Dr. | +4915785128140 | annelena.held@fcre.eu |
Locations
| Germany | |
| University Hospital Aachen | Recruiting |
| Aachen, Germany | |
| Contact: Drosos Kotelis, Prof. Dr. | |
| University Heart Center Freiburg- Bad Krozingen | Not yet recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Martin Czerny | |
| University Hospital Gießen | Recruiting |
| Gießen, Germany | |
| Contact: Johannes Kalder, Dr. | |
| University Hospital Hamburg-Eppendorf | Not yet recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Tilo Kölbel | |
| University Hospital LMU Munich | Recruiting |
| München, Germany | |
| Contact: Nikolaos Tsilimparis, Prof. Dr. | |
| St. Franziskus Hospital | Recruiting |
| Münster, Germany, 48145 | |
| Contact: Michel Bosiers, Dr. | |
| Klinikum Nürnberg Süd | Recruiting |
| Nürnberg, Germany | |
| Contact: Eric Verhoeven, Prof. Dr. | |
| University Hospital Regensburg | Recruiting |
| Regensburg, Germany | |
| Contact: Kyriakos Oikonomou, Dr. | |
| Hospital Stuttgart | Not yet recruiting |
| Stuttgart, Germany | |
| Contact: Philipp Geisbüsch, Prof. Dr. | |
Sponsors and Collaborators
Prof. Giovanni Torsello
Investigators
| Study Director: | Giovanni Torsello, Prof. Dr. | Foundation for Cardiovascular Research and Education |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 12, 2019 | ||||||||
| First Posted Date ICMJE | June 14, 2019 | ||||||||
| Last Update Posted Date | May 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | March 18, 2021 | ||||||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | BGP Stent as Bridging Stent in FEVAR | ||||||||
| Official Title ICMJE | Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms | ||||||||
| Brief Summary | The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Application of BeGraft Peripheral Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent
BGP Stent Graft System as bridging stent
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| Study Arms ICMJE | Experimental: BGP Stent Graft System
BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
Intervention: Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2023 | ||||||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 55 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03987035 | ||||||||
| Other Study ID Numbers ICMJE | FCRE-200504 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education) | ||||||||
| Study Sponsor ICMJE | Prof. Giovanni Torsello | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | FCRE (Foundation for Cardiovascular Research and Education) | ||||||||
| Verification Date | May 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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