Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention: A Randomized Trial of Routine PCI Versus CCTA-guided PCI (CT-PLAN-PCI)
연구 개요
상세 설명
CCTA provides comprehensive anatomical characterization of coronary arteries, including plaque morphology. It allows assessment of the origin and course of the coronaries, proximal and distal reference vessel dimensions, which can inform landing zones for stent length selection, and stent sizing. CCTA also enables comprehensive physiological assessment through fractional flow reserve (FFRCT), including FFRCT pullback for disease pattern characterization and delta FFRCT. In addition, CCTA can estimate vessel-specific myocardial mass to support bifurcation PCI planning and may assist intra-procedural guidance through CT co-registration. Whether CCTA-guided PCI is non-inferior to an intravascular ultrasound (IVUS) guided PCI strategy is being evaluated in the Precise Procedural and PCI Plan (P4) randomized clinical trial (NCT05253677). P4 enrolled approximately 1,100 patients and is evaluating the incidence of major adverse cardiovascular events (cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization) between CT- and IVUS-guided PCI at 12-months. While this landmark trial is expected to provide the first randomized data to support CT-guided PCI, broader clinical adoption remains limited by the need for multiple software platforms and investigational applications.
While promising, there are limited prospective and/or randomized data showing that CT-guided PCI is superior to standard of care. Early U.S. experience using coronary computed tomography angiography (CCTA) for percutaneous coronary intervention (PCI) planning highlighted the emerging role of CCTA to inform case complexity, equipment utilization, lesion morphology and non-invasive coronary physiology. Despite these promising findings, these studies were small, single-center, and non-controlled. To demonstrate clinical value, a randomized controlled trial comparing CCTA guided PCI with standard PCI would be necessary to determine whether this approach yields similar or superior outcomes in broader patient populations.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55407
- Minneapolis Heart Institute Foundation
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수석 연구원:
- Yader Sandoval, MD
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연락하다:
- Olga Mastrodemos
- 전화번호: 612-863-4768
- 이메일: olga.mastrodemos@allina.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- At least one moderate-severe coronary stenosis on CCTA with an FFRCT ≤0.80 involving no more than two vessels (i.e. target lesion(s) must be FFRCT eligible)
- Referral for non-emergent PCI of at least one de novo stenosis in a native coronary artery with a reference diameter ≥2 mm on CCTA.
Exclusion Criteria:
- Multivessel CAD involving ≥3 vessels.
- Severe left main disease >50%
- Prior CABG
- Prior PCI in target vessel
- Planned CABG
- Chronic coronary total occlusion in the target vessel
- ST-elevation myocardial infarction
- Emergent PCI
- Cardiac arrest
- Cardiogenic shock
- Scenarios where FFRCT is not possible: inadequate CCTA quality for FFRCT, small vessels <2 mm, with stents at the target vessel.
- Unstable high-risk NSTE-ACS (hemodynamic instability, refractory angina, unstable arrhythmias, persistent ischemia).
- Patients who are pregnant or nursing or plan to be pregnant in the period up to 2 years following the index procedure will not be approached due to exposure to fluoroscopy.
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: CT-guided PCI
Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator
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Participants randomized to CT-guided PCI will have their clinically available CCTAs analyzed using commercially available software to create a pre-procedural plan, which will be used to help guide the procedure
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활성 비교기: Routine PCI
Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT
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Participants randomized to routine PCI will not have their CCTA's analyzed pre-procedure.
The investigator may use intravascular imaging and pre-PCI FFR, but these are not mandated.
The investigator will use the information obtained from the coronary angiogram to treat any coronary artery disease that is present.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Procedural time
기간: intra-procedural
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procedural time, defined as the time between the first to the final angiographic image acquisition
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intra-procedural
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Contrast volume
기간: intra-procedural
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The volume of contrast used during the index procedure
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intra-procedural
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Radiation dose
기간: intra-procedural
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The dose of radiation used during the index procedure
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intra-procedural
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Fluoroscopy time
기간: intra-procedural
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The amount of time during the procedure that fluoroscopy was used
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intra-procedural
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Post-PCI pressure wire based FFR
기간: intra-procedural
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Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time
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intra-procedural
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Use of advanced calcium modification techniques
기간: intra-procedural
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intra-procedural
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Resource utilization
기간: intra-procedural
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number of diagnostic or guide catheters used, equipment usage throughout the case
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intra-procedural
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PCI Complications and Incidence of MACE During Index Procedure
기간: intra-procedural
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incidence of major adverse cardiac events during the index procedure
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intra-procedural
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Peri-procedural myocardial injury and infarction
기간: Peri-procedural
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Incidence of myocardial injury and infarction after the index procedure, during hospitalization
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Peri-procedural
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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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