새로운 흐름 전환기 세대에서 동맥류 치료를 최적화하기 위한 코팅 (COATING)
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Augsburg, 독일, 86156
- Universitätsklinikum Augsburg
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Erfurt, 독일, 99089
- Helios Klinikum Erfurt
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Halle, 독일, 06120
- Universitätsklinikum Halle (Saale)
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München, 독일, 81377
- Klinikum der LMU München
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Nuremberg, 독일, 90471
- Klinikum Nürnberg Süd
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Recklinghausen, 독일
- Klinikum Vest Recklinghausen
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Stuttgart, 독일, 70174
- Klinikum Stuttgart
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Basel, 스위스, 4051
- Universitätsspital Basel
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Košice, 슬로바키아, 04190
- UNLP Košice
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Birmingham, 영국, B15 2GW
- Queen Elisabeth Hospital Birmingham
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Edinburgh, 영국
- Western General Hospital
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Jerusalem, 이스라엘, 9112001
- Hadassah University Medical Center
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Milan, 이탈리아, 20133
- Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
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Bordeaux, 프랑스, 33076
- CHU Bordeaux
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Le Kremlin-Bicêtre, 프랑스, 94270
- Hôpital Bicêtre
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Lyon, 프랑스, 69002
- CHU de Lyon
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Montpellier, 프랑스, 34090
- CHU de Montpellier
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Reims, 프랑스, 51092
- CHU Reims - Hôpital Maison Blanche
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 18 years of age.
- Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
- Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
- Subject has already been selected for flow diversion therapy as the appropriate treatment.
- Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
- Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).
Exclusion Criteria:
- Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
- Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
- Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
- Subject with target aneurysm previously treated with a stent or flow diverter.
- Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
- Subject with a confirmed stenosis in parent artery.
- Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
- Subject has a pre-procedure mRS >2.
- Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
- Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
- Known serious sensitivity to radiographic contrast agents.
- Known sensitivity to nickel, titanium metals, or their alloys.
- Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
- Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
- Subject who has a contraindication to MRI or angiography for whatever reason.
- Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- Subject with any known allergy to heparin, ASA or other antiplatelet medications.
- Subject with coagulation disorder
- Pregnant woman or breast feeding.
- Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: p64 MW HPC 흐름 전환기 + SAPT
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Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device. |
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실험적: p64 MW 유량 전환기 + DAPT
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Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of DWI lesions
기간: 48 hours (± 24 hours)
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Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI. |
48 hours (± 24 hours)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short-term morbi-mortality rate
기간: 30 days (± 7 days)
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Morbi-mortality rate at 30 days assessed by mRS > 2 |
30 days (± 7 days)
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Rate of neurological death or major stroke
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Long-term morbi-mortality rate
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of subjects with dissusion-weighted imaging (DWI) lesions
기간: 48 hours (± 24 hours)
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Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke |
48 hours (± 24 hours)
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Delayed aneurysm rupture
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Delayed intraparenchymal hemorrhage
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of peripheral bleeding
기간: Any event reported from discharge to 365 days (335 - 456 days) post procedure
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Rate of peripheral bleeding, as assessed by the Clinical Events Committee |
Any event reported from discharge to 365 days (335 - 456 days) post procedure
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Rate of device deployment at the target site without technical complications
기간: During intervention
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Rate of device deployment at the target site without technical complications, as assessed by the site |
During intervention
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Rate of complete aneurysm occlusion
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm recurrence
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm retreatment
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of intrastent stenosis and/or thrombosis at the target site
기간: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Mean length of hospital stay
기간: From admission up to discharge, assessed up to 456 days
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Mean length of hospital stay (from hospital admission and up to hospital discharge) |
From admission up to discharge, assessed up to 456 days
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Laurent Pierot, Prof. Dr., CHRU Hôpital Maison-Blanche
간행물 및 유용한 링크
일반 간행물
- Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspotter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24.
- Ramirez-Velandia F, Enriquez-Marulanda A, Filo J, Young M, Fodor TB, Sconzo D, Muram S, Granstein JH, Shutran M, Taussky P, Ogilvy CS. Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis. Neurosurgery. 2024 Aug 1;95(2):330-338. doi: 10.1227/neu.0000000000002883. Epub 2024 Feb 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .