- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05301218
CAlcified Lesion Intervention Planning Steered by OCT. (CALIPSO)
Calcified lesions are very frequent among coronary artery disease stenotic lesions.
The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nicolas Amabile, MD PhD
- 전화번호: 33 0156616983
- 이메일: nicolas.amabile@imm.fr
연구 연락처 백업
- 이름: Silvia Burbassi, PhD
- 전화번호: 33 0156616983
- 이메일: silvia.burbassi@imm.fr
연구 장소
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Bastia, 프랑스, 20600
- 모병
- CH de Bastia
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연락하다:
- Ziad Boueri, MD
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Besançon, 프랑스, 25000
- 모병
- CHU de Besancon
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연락하다:
- Nicolas Meneveau, MD
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Bordeaux, 프랑스, 33000
- 모병
- CHU de Bordeaux
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연락하다:
- Benjamin Séguy, MD
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Bordeaux, 프랑스, 33200
- 모병
- Clinique Saint Augustin
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연락하다:
- Frederic Casassus, MD
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Clermont-Ferrand, 프랑스, 63000
- 모병
- CHU de Clermont-Ferrand
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연락하다:
- Géraud SOUTEYRAND, MD
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Le Coudray, 프랑스, 28630
- 모병
- Hôpital Louis Pasteur
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연락하다:
- Grégoire RANGé Rangé, MD
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Nantes, 프랑스, 44000
- 모병
- L'Hôpital privé du Confluent
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연락하다:
- Erwan BRESSOLLETTE, MD
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Nîmes, 프랑스, 30029
- 모병
- Chu Nimes
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연락하다:
- Guillaume Cayla, MD
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Ollioules, 프랑스, 83190
- 모병
- Polyclinique Les Fleurs
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연락하다:
- Philippe Commeau, MD
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Poitiers, 프랑스, 86000
- 모병
- CHU de Poitiers
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연락하다:
- Sébastien Levesque, MD
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Rouen, 프랑스, 76000
- 모병
- Clinique Saint-Hilaire
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연락하다:
- Quentin LANDOLFF, MD
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Saint-Laurent-du-Var, 프랑스, 06700
- 모병
- Institut Arnaud Tzanck,
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연락하다:
- Julien ADJEDJ, MD
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Toulouse, 프랑스, 31300
- 모병
- Clinique PASTEUR
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연락하다:
- Benjamin HONTON, MD
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Ile De France
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Paris, Ile De France, 프랑스, 75014
- 모병
- Institut Mutualiste Montsouris
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연락하다:
- Silvia Burbassi, PhD
- 전화번호: 33 0156616983
- 이메일: silvia.burbassi@imm.fr
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수석 연구원:
- Nicolas Amabile, MD PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient with chronic coronary syndrome
Angiographically moderately to severely calcified target lesion, defined as follows:
- Moderate: lesion with radio-opacities noted only during the cardiac cycle before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
- Severe: lesion with radio-opacities seen without cardiac motion before contrast dye injection, visible on both sides of the arterial lumen(Aksoy et al., Circ Cardiovasc Interv 2019)
- Possibility to cross the target lesion with OCT catheter
Exclusion Criteria:
- On-going cardiogenic shock
- Acute coronary syndrome related to target lesion
- Severe renal failure (Creatinine clearance: 30 ml/min/m2)
- Impossibility to cross target lesion with OCT catheter & balloons,
- Indication for Rotablator device as first line therapy
- Pregnancy
- Age < 18 y
- Denial to provide consent
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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활성 비교기: angiography-guided group
the treatment (including lesion preparation, stent sizing and post implantation optimization) will be performed by angiography.
Once the result is considered optimal by the operator, a control OCT run will be acquired.
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Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries.
Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart
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실험적: OCT-guided group
a preliminary OCT run will be recorded.
An initial predilation with 1.5 to 2.0 mm balloon could be accepted in order to facilitate OCT catheter delivery through the target lesion.
The PCI strategy will be guided by a pre-defined algorithm based on initial OCT findings.
Post PCI result will be assessed by control OCT and potential optimization steps could be applied according to the results.
The MLD-MAX optimization approach will be applied.
Final OCT run will be performed at the end of the procedure.
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Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries.
Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
기간: During the procedure
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The crude minimal stent area (MSA) will be measured along the stent on the target lesion.
Stent geometric expansion will be evaluated by the DOCTORS criteria for non-bifurcated segments (Meneveau et, Circulation 2016) and LEMON criteria for bifurcated segments (Amabile et al;, Eurointervention 2020).
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During the procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria
기간: during procedure
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After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.
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during procedure
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Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)
기간: during procedure
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Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations
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during procedure
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Residual major struts malapposition: crude incidence and quantification
기간: during procedure
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malapposition was defined as a lack of contact of at least 1 strut with the underlying vessel wall (at least 150 μm, in the absence of a side branch) with evidence of blood flow behind the strut.
It was classified as "major" malapposition if there was evidence of at least 30% of the struts in one frame.
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during procedure
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Major adverse cardiovascular events at 30 days and 1 year
기간: at 30 days and 1 year
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Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)
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at 30 days and 1 year
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Peri-procedural MI according to the SCAI definition (23)
기간: during procedure
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according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)
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during procedure
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Coronary artery perforation: incidence
기간: during the procedure and During the full participation period (1 year).]
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Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure
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during the procedure and During the full participation period (1 year).]
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Radiation dose
기간: during procedure
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Differences in dose radiation used during le procedure
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during procedure
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Total Contrast medium volume
기간: during procedure
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Differences in amount of contrast drug used during le procedure
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during procedure
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Procedure duration
기간: 24th post-operative hour
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differences in duration (time) of the procedure
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24th post-operative hour
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Nicolas Amabile, MD PhD, Institut Mutualiste Montsouris
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
기타 연구 ID 번호
- CARDIO 04 2021
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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