Physiologic Assessment of Coronary Stenosis Following PCI

NCT03084367 | Completed Results

• 1 other identifier: 160101
• Study Type: observational
• Target: 500
• Locations: 3 countries
• Sites: 28

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Residual Ischemia (iFR <0.90)

  Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography.

  end of procedure/intervention

Secondary Outcomes (11)

• Cardiac Events

  12 months

• Target Vessel Failure

  12 months

• Quality of Life Change From Baseline to 12 Months Follow-up

  12 months

• Cardiac Mortality

  12 months

• Target Vessel MI

  12 month

Study Arms (1)

iFR post angiographically successful PCI

Diagnostic Test: iFR pullback

Interventions

iFR pullback DIAGNOSTIC_TEST

iFR pullback assessment post angiographically successful PCI

iFR post angiographically successful PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consented subjects with CAD who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation

You may qualify if:

• Subject must be \> 18 years old
• Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
• 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
• Pre-PCI iFR performed in all vessels intended for PCI
• Pre-PCI iFR of \<0.90 of at least 1 stenosis
• Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

You may not qualify if:

• Pregnant or planning to become pregnant for the duration of the study
• Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
• Cardiogenic shock (sustained (\>10 min) systolic blood pressure \< 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
• Ionotropic or temporary pacing requirement
• Sustained ventricular arrhythmias
• Prior CABG (Coronary Artery Bypass Graft)
• Known ejection fraction ≤30%
• Chronic Total Occlusion (CTO)
• Known severe mitral or aortic stenosis.
• Any known medical comorbidity resulting in life expectancy \< 12 months.
• Participation in any investigational study that has not yet reached its primary endpoint.
• Known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2).
• TIMI flow \<3 at baseline
• Intra-coronary thrombus on baseline angiography

Sponsors & Collaborators

• Volcano Corporation: lead
• Duke Clinical Research Institute: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (28)

VA Medical Center

Long Beach, California, 90822, United States

Location

Colorado Heart and Vascular

Lakewood, Colorado, 80204, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Rockford CV Associates

Rockford, Illinois, 61107, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

South Side Hospital

Bay Shore, New York, 11706, United States

Location

Northshore Hospital

Manhasset, New York, 11030, United States

Location

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

New York Presbyterian Hospital -Weill Cornell

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St Francis Hospital

Roslyn, New York, 11576, United States

Location

SUNY- Stony Brook

Stony Brook, New York, 11794, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27835, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont CVA Heart Insitute

Kingsport, Tennessee, 37660, United States

Location

VA North Texas Health Care

Dallas, Texas, 75216, United States

Location

Aurora St Lukes Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

AMC Amsterdam

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Basildon Univeristy Hospital

Basildon, SS165NL, United Kingdom

Location

Royal Bournemouth hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX25DW, United Kingdom

Location

Imperial College of London- Hammersmith Hospital

London, W12OHS, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31648761 RESULT

• 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.

  PMID: 34991824 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Becky Inderbitzen, Global Director, Clinical Development
• Organization: Philips (Volcano)

becky.inderbitzen@philips.com

+1.858.764.1336

Study Officials

• Becky Inderbitzen, MSE

  Philips (Volcano)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 20, 2017
• Study Start: June 20, 2017
• Primary Completion: January 18, 2019
• Study Completion: February 18, 2020
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-02

Locations

US (22); NL (2); GB (4)