The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study (BIFSORB)
Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study
연구 개요
상세 설명
BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions.
BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.
The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS.
Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS.
Methods:
Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years.
Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS.
The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure.
The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT.
Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Stable angina pectoris
- Age > 18 years
- Stabilized non-ST elevation myocardial infarction
- Silent angina
- De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
- All Medina classes except Medina x.x.1
- Diameter of side branch ≥ 2.5 mm
- Signed informed consent
Exclusion Criteria:
- ST-elevation infarction within 48 hours
- Expected survival < 1 year
- Severe heart failure (NYHA≥III)
- S-creatinine > 120 µmol/L
- Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
- Unable to cover main vessel lesion with one scaffold
- Severe tortuosity
- Severe calcification
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: Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
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Randomization to implantation of Absorb BVS in bifurcation lesion
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실험적: Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion
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Randomization to implantation of Desolve BRS in bifurcation lesion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
기간: 6 months
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Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
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6 months
|
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Index of adverse vessel wall features
기간: 6 months
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Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
광학 일관성 단층 촬영 끝점: 지주에 급성 혈전
기간: 기준선
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기준선
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혈관조영 종료점: 주혈관 스텐트 삽입 후 정공 측 분지 급성 이득
기간: 기준선
|
기준선
|
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혈관조영 종료점: 주혈관 스텐트 삽입 후 원위부 주혈관 급성 증가
기간: 기준선
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기준선
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혈관조영 종점: 주혈관 스텐트 삽입 후 근위부 주혈관 급성 증가
기간: 기준선
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기준선
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Optical coherence tomography endpoint: acute malapposition
기간: Baseline
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Baseline
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Optical coherence tomography endpoint: acquired malapposition
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: persistent malapposition
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Coverage of jailing struts
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Late stent recoil
기간: 6 and 24 months
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6 and 24 months
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|
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Optical coherence tomography endpoint: stent fracture
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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|
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Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Ostial strut loss
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Mean neointimal thickness
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Stent strut coverage
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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|
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Optical coherence tomography endpoint: Minimal stent area in segmental analysis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Minimum scaffold expansion area %
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Segmental area stenosis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Optical coherence tomography endpoint: Healing above calcified plaque
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Healing above lipid plaque
기간: 6 and 24 months
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6 and 24 months
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Optical coherence tomography endpoint: Late thrombus on struts
기간: 6 and 24 months
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6 and 24 months
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|
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Optical coherence tomography endpoint: Acute expansion
기간: Baseline
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Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
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Baseline
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Optical coherence tomography endpoint:Late recoil
기간: 6 and 24 months
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Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
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6 and 24 months
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Angiographic endpoint: Ostial side branch area stenosis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Angiographic endpoint: Ostial side branch late loss
기간: 6 and 24 months
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6 and 24 months
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Angiographic endpoint: Ostial distal main vessel area stenosis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Angiographic endpoint: Ostial distal main vessel late loss
기간: 6 and 24 months
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6 and 24 months
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Angiographic endpoint: Proximal main vessel area stenosis
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Angiographic endpoint: Proximal main vessel late loss
기간: 6 and 24 months
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6 and 24 months
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Angiographic endpoint: Minimal luminal area of all segments
기간: Baseline, 6 and 24 months
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Baseline, 6 and 24 months
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Procedural endpoints: Procedure time
기간: Baseline
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From sheath insertion to closure device excluding treatment of other vessels
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Baseline
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Procedural endpoints: Contrast use
기간: Baseline
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Baseline
|
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Procedural endpoints: Fluoroscopy time
기간: Baseline
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Baseline
|
기타 결과 측정
결과 측정 |
기간 |
|---|---|
|
Clinical endpoints: Myocardial infarction
기간: 10 years
|
10 years
|
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Clinical endpoints: Target lesion failure
기간: 10 years
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10 years
|
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Clinical endpoints: Target lesion revascularization
기간: 10 years
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10 years
|
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Clinical endpoints: Stent thrombosis
기간: 10 years
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10 years
|
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Clinical endpoints: Cardiac death
기간: 10 years
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10 years
|
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Clinical endpoints: Non-Cardiac death
기간: 10 years
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10 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Evald H Christiansen, MD, PhD, Aarhus University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- 1-10-72-215-14
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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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