Physiologic Assessment of Coronary Stenosis Following PCI

NCT ID: NCT03084367

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2020-02-18

Brief Summary

This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).

Detailed Description

DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Conditions

Coronary Artery Disease; Coronary Stenosis; Angina, Unstable; Angina, Stable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

iFR post angiographically successful PCI

iFR pullback

Intervention Type: DIAGNOSTIC_TEST

iFR pullback assessment post angiographically successful PCI

Interventions

iFR pullback

iFR pullback assessment post angiographically successful PCI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Subject must be > 18 years old

2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)

3. Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis

4. Pre-PCI iFR performed in all vessels intended for PCI

5. Pre-PCI iFR of <0.90 of at least 1 stenosis

6. Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria

1. Pregnant or planning to become pregnant for the duration of the study

2. Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days

3. Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).

4. Ionotropic or temporary pacing requirement

5. Sustained ventricular arrhythmias

6. Prior CABG (Coronary Artery Bypass Graft)

7. Known ejection fraction ≤30%

8. Chronic Total Occlusion (CTO)

9. Known severe mitral or aortic stenosis.

10. Any known medical comorbidity resulting in life expectancy < 12 months.

11. Participation in any investigational study that has not yet reached its primary endpoint.

12. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).

13. TIMI flow <3 at baseline

14. Intra-coronary thrombus on baseline angiography

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: collaborator

Volcano Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Becky Inderbitzen, MSE

Role: STUDY_DIRECTOR

Philips (Volcano)

Locations

VA Medical Center

Long Beach, California, United States

Colorado Heart and Vascular

Lakewood, Colorado, United States

Emory University Hospital

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Rockford CV Associates

Rockford, Illinois, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

South Side Hospital

Bay Shore, New York, United States

Northshore Hospital

Manhasset, New York, United States

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, United States

New York Presbyterian Hospital -Weill Cornell

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St Francis Hospital

Roslyn, New York, United States

SUNY- Stony Brook

Stony Brook, New York, United States

Duke University Hospital

Durham, North Carolina, United States

Vidant Medical Center

Greenville, North Carolina, United States

Miriam Hospital

Providence, Rhode Island, United States

Wellmont CVA Heart Insitute

Kingsport, Tennessee, United States

VA North Texas Health Care

Dallas, Texas, United States

Aurora St Lukes Medical Center

Milwaukee, Wisconsin, United States

AMC Amsterdam

Amsterdam, , Netherlands

VU University Medical Center

Amsterdam, , Netherlands

Basildon Univeristy Hospital

Basildon, , United Kingdom

Royal Bournemouth hospital

Bournemouth, , United Kingdom

Royal Devon & Exeter NHS Foundation Trust

Exeter, , United Kingdom

Imperial College of London- Hammersmith Hospital

London, , United Kingdom

Countries

United States; Netherlands; United Kingdom

References

Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.

Reference Type: RESULT

PMID: 31648761 (View on PubMed)

Patel MR, Jeremias A, Maehara A, Matsumura M, Zhang Z, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp ASP, Ali ZA, Mintz G, Davies J, Stone GW. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovasc Interv. 2022 Jan 10;15(1):52-61. doi: 10.1016/j.jcin.2021.09.042.

Reference Type: DERIVED

PMID: 34991824 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

160101

Identifier Type: -

Identifier Source: org_study_id