免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / BGP+ Stent as Bridging Stent in BEVAR
BGP+ Stent as Bridging Stent in BEVAR
Study Description
Brief Summary:
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture | Device: 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 Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR for Complex Aortic Aneurysms |
| Actual Study Start Date : | September 9, 2020 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BGP+ Stent Graft System
Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
|
Device: 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 ]defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR
- 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 - 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 :
- Bridging stent patency post-procedure [ Time Frame: 1 day post-op, 6- and 24- months post-op ]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- and 24- months post-op ]Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)
- Freedom from bridging stent related secondary intervention [ Time Frame: 1 day post-op, 6-, 12- and 24- months post-op ]Freedom from bridging stent related secondary intervention
- Freedom from type I & III endoleaks post-procedure post-procedure [ Time Frame: 1 day post-op, 6-, 12-, and 24- months post-op ]Freedom from type I & III endoleaks post-op 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 [ 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 post-op implantation, based on imaging (duplex ultrasound or CT Angiography)
- Freedom from aneurysm related secondary endovascular procedures [ Time Frame: 1 day post-op, at 6-, 12- and 24- months post-op ]Freedom from aneurysm related secondary endovascular procedures post-op
- Freedom from conversion to open surgical repair post-procedure [ Time Frame: 1 day post-op, 6-, 12-, 24- months post-op ]Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months
- Freedom from aneurysm related mortality post-procedure [ Time Frame: 1 day post-op, 6-, 12-, 24- months post-op ]
- Freedom from aneurysm rupture post-implantation [ Time Frame: up to 12- and 24- months post-op ]Freedom from aneurysm rupture within 12- and 24-months post-implantation
- Freedom from any major adverse events post-procedural and at 6 and 12 months [ Time Frame: 1 day post-op, 6-, 12- and 24- months post-op ]
- 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 TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm 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 enrolment in the trial
- Patient has a projected life-expectancy of at least 12-months
- Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm.
- The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath)
- 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
Exclusion Criteria:
- Previously implanted stent in the target vessel
- Renal artery with >100° cranial orientation
- Patients refusing treatment
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Any planned surgical intervention/procedure within 30 days of the trial procedure
- Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device trial that has not completed the entire follow up period.
- Patients with diffuse distal disease resulting in poor stent outflow
- Fresh thrombus formation
- 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. | 0049 15785128140 | annelena.held@fcre.eu |
Locations
| Germany | |
| University Hospital Aachen | Recruiting |
| Aachen, Germany | |
| Contact: Drosos Kotelis, Prof. Dr. | |
| University Hospital Eppendorf, UKE Hamburg | Recruiting |
| Hamburg, Germany | |
| Contact: Kölbel Tilo, Prof. Dr. | |
| University Hospital Leipzig | Recruiting |
| Leipzig, Germany | |
| Contact: Dierk Scheinert, Prof. Dr. | |
| University Hospital LMU Munich | Recruiting |
| Munich, Germany | |
| Contact: Nikolaos Tsilimparis, Prof. Dr. | |
| St. Franziskus Hospital | Recruiting |
| Münster, Germany, 48145 | |
| Contact: Martin Austermann, Dr. | |
| Klinikum Nürnberg Süd | Recruiting |
| Nürnberg, Germany | |
| Contact: Eric Verhoeven, Prof. Dr. | |
| Principal Investigator: Eric Verhoeven, Prof. Dr. | |
| Sub-Investigator: Athanasios Katsargyris, 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 6, 2019 | ||||||||
| First Posted Date ICMJE | June 12, 2019 | ||||||||
| Last Update Posted Date | May 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 9, 2020 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| 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 BEVAR | ||||||||
| Official Title ICMJE | Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR 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 BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched 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 Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms Masking: None (Open Label)Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture | ||||||||
| Intervention ICMJE | Device: BGP+ Stent Graft System as bridging stent
BGP+ Stent Graft System as bridging stent
|
||||||||
| Study Arms ICMJE | Experimental: BGP+ Stent Graft System
Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Intervention: Device: BGP+ Stent Graft System as bridging stent
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 55 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03982940 | ||||||||
| Other Study ID Numbers ICMJE | FCRE-190129 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education) | ||||||||
| Study Sponsor ICMJE | Prof. Giovanni Torsello | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | FCRE (Foundation for Cardiovascular Research and Education) | ||||||||
| Verification Date | May 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
