Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
연구 개요
상세 설명
PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.
The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥ 18 and ≤80
- Patients diagnosed with CTO by coronary angiography
- Patient planned to receive PCI
- Diameter of CTO vessel > 2.25 mm
Exclusion Criteria:
- Age >80 or <18
- Myocardial infarction with 1 months
- Inability to give informed consent
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline FFR at 6 months after CTO PCI
기간: At baseline and 6 months after CTO PCI
|
FFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
FFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The FFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
|
Change from Baseline FFR at 6 months after CTO PCI
기간: At baseline and 6 months after CTO PCI
|
CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
|
Change from Baseline Myocardial perfusion at 6 months after CTO PCI
기간: At baseline and 6 months after CTO PCI
|
The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.
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At baseline and 6 months after CTO PCI
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Change from Baseline Myocardial Viability at 6 months after CTO PCI
기간: At baseline and 6 months after CTO PCI
|
The myocardial viability before and after CTO PCI was evaluated by PET-MRI.
|
At baseline and 6 months after CTO PCI
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MACE
기간: 6 months after CTO PCI
|
A major adverse cardiac event (MACE) was defined as the occurrence of cardiac death, nonfatal MI, and target lesion revascularization during the follow-up period.
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6 months after CTO PCI
|
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In-stent restenosis
기간: 6 months after CTO PCI
|
In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.
|
6 months after CTO PCI
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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 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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