Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study (SMARTFLOW)
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating:
- Fractional flow reserve (FFR) and
- Detection of coronary microvascular disease (CMD)
SMARTFLOW is a prospective, single-arm, observational multicenter study of patients with suspected coronary artery disease (CAD) undergoing clinically indicated invasive coronary angiography with physiological assessment. The study is designed to prospectively enroll patient cohorts and collect data according to their reference procedures (e.g. FFR, CFR measures). A core lab will evaluate performance of the AngioAI+ software retrospectively using the collected SMARTFLOW study data. As such, the investigational AngioAI+ device will not inform clinical decisions amid the study procedure.
연구 개요
상태
상세 설명
All patients will undergo clinically indicated invasive coronary angiography with physiological assessment according to standard of care.
Cohort 1: Patients with intermediate lesions (30-90% diameter stenosis) will undergo invasive FFR assessment. In patients with FFR >0.80 (non-flow limiting stenosis), subsequent assessment of the microcirculation with bolus and continuous thermodilution will be performed.
Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
For patients in Cohort 1 with FFR ≤0.80 undergoing percutaneous coronary interventions (PCI), FFR measurements after PCI will be recommended. Use of intravascular imaging will be strongly encouraged to guide PCI procedures, in accordance with current practice guidelines.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sr. VP Regulatory Affairs - AngioInsight
- 전화번호: 16122675004
- 이메일: gzaeska@angioinsight.com
연구 연락처 백업
- 이름: Project Manager - Cardiovascular Research Foundation
- 이메일: jungarten@crf.org
연구 장소
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California
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Palo Alto, California, 미국, 94304
- Stanford University
-
수석 연구원:
- William Fearon, MD
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연락하다:
- Archana Verma, MD
- 전화번호: 650-497-6299
- 이메일: varchana@stanford.edu
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Palo Alto, California, 미국, 94304
- Palo Alto Veterans Administration Hospital
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수석 연구원:
- William Fearon, MD
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연락하다:
- Calvert Lee
- 전화번호: 650-239-2808
- 이메일: CLee@pavir.org
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- Washington Hospital Center
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수석 연구원:
- Hayder Hashim, MD
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연락하다:
- Eric Suchanec
- 전화번호: 202-877-7207
- 이메일: eric.suchanec@medstar.net
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Minnesota
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Minneapolis, Minnesota, 미국, 55407
- Minneapolis Heart
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연락하다:
- Bavana Rangan
- 전화번호: 612-863-3852
- 이메일: Bavana.Rangan@allina.com
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수석 연구원:
- Yader Sandoval, MD
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New Jersey
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Paramus, New Jersey, 미국, 07652
- Valley Health System
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연락하다:
- Kimberly Michel
- 전화번호: 201-447-8453
- 이메일: KMICHEL@Valleyhealth.com
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수석 연구원:
- Rajiv Tayal, MD
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New York
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New York, New York, 미국, 10016
- New York University
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수석 연구원:
- Nathaniel Smilowitz, MD
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연락하다:
- Manuela Plazas Montana
- 전화번호: 917-921-6436
- 이메일: Manuela.PlazasMontana@nyulangone.org
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New York, New York, 미국, 10075
- Northwell Health
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연락하다:
- Virgenmina Lugaro
- 전화번호: 212-434-6626
- 이메일: VLugaro@northwell.edu
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수석 연구원:
- Michael C Kim, MD
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Ohio
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Cincinnati, Ohio, 미국, 45219
- Christ Hospital
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수석 연구원:
- Tim Henry, MD
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연락하다:
- Rebecca Harper
- 전화번호: 513-585-2000
- 이메일: RebeccaM.Harper@thechristhospital.com
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Tennessee
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Nashville, Tennessee, 미국, 37205
- Ascension Saint Thomas
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수석 연구원:
- Jimmy Kerrigan, MD
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연락하다:
- Amelia Drennan
- 전화번호: 615-222-3815
- 이메일: amelia.drennan@ascension.org
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated coronary physiologic assessment. In patients with acute coronary syndromes, the physiological evaluation will be restricted to non-culprit vessels.
- Patients with intermediate CAD (30-90% visual stenosis) with clinically indicated FFR assessment.
- Patients with NOCAD (<30% visual stenosis) with clinically indicated microvascular assessment.
Exclusion Criteria:
- Patients presenting with ST-elevation
- Prior myocardial infarction in the target vessel
- Stent implantation in the target vessel within the last 12 months
- Previous coronary artery bypass grafting surgery (CABG)
- Previous heart valve surgery
- Previous heart transplantation
- Moderate-to-severe valvular disease
- Left ventricular ejection fraction (EF) ≤45%
- Hemodynamic instability or cardiogenic shock
Angiographic Exclusion Criteria
- Left main stenosis≥50%
- Chronic total occlusion in the target vessel
- CTO in a non-target vessel
- Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel
- Target vessel receiving collaterals
- Inadequate coronary angiographic images
- Ostial lesions
- Severe tortuosity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cohort 1
Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
|
Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.
|
|
Cohort 2
Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
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Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
기간: June 2026 to December 2027
|
1. Per-vessel diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ FFR for identifying flow-limiting lesions, using measured FFR as the reference standard.
|
June 2026 to December 2027
|
|
To establish the diagnostic performance of AngioAI+ System
기간: June 2026 to December 2027
|
Description: 2. Diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ for detecting CMD in patients with non-obstructive CAD using invasive coronary flow reserve (CFR) derived from continuous thermodilution as reference.
|
June 2026 to December 2027
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
- 수석 연구원: Todd C Villines, MD, University of Virginia
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. .