Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study

NCT04929496 | Active Not Recruiting

• 1 other identifier: EASY-PREDICT pilot study
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.

Conditions

Coronary Artery Disease; Stable Angina; Unstable Angina; Ischemic Heart Disease; Chest Pain

Keywords

Coronary Artery Disease; Fractional Flow Reserve; Post-PCI FFR; Angiography; Angioplasty

Outcome Measures

Primary Outcomes (2)

• Rate of Target Vessel Failure

  as the composite of cardiac death, lesion-related MI and target vessel revascularization

  within 18 months after index PCI;

• Rate of angina-related events

  defined as hospitalization for unstable angina and unsolicited medical visits for angina

  within 18 months after index PCI;

Secondary Outcomes (6)

• Final post-PCI pressure ratio values according to lesion location and intervened vessels

  Post-randomization after stent implantation (< 1 hour)

• Final post-PCI FFR values according to lesion location and intervened vessels

  Post-randomization after stent implantation (< 1 hour)

• Final post-PCI dPR values according to lesion location and intervened vessels

  Post-randomization after stent implantation (< 1 hour)

• Final post-PCI physiology pullback curves according to lesion location and intervened vessels

  Post-randomization after stent implantation (< 1 hour)

• Rates of unstable angina requiring hospitalization or unsolicited medical visits

  within 18 months of index procedure

Study Arms (2)

Angiographical guidance only

NO INTERVENTION

Standard of care

Post-PCI FFR guidance

EXPERIMENTAL

Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement

Procedure: post-PCI FFR

Interventions

post-PCI FFR PROCEDURE

final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Also known as: Fractional Flow Reserve, Non-hyperemic pressure ratios

Post-PCI FFR guidance

Eligibility Criteria

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

You may qualify if:

• Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
• Successful (\< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
• All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)

You may not qualify if:

• Lesion in saphenous vein or arterial grafts
• Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
• Sub-optimal PCI result ( \>30% residual diameter stenosis and/or \<TIMI3 flow) or peri-procedural complications
• Acute ST-Elevation MI (culprit lesion)

Sponsors & Collaborators

• Laval University: lead
• Opsens, Inc.: collaborator
• International Chair on Interventional Cardiology and Transradial Approach: collaborator

Study Sites (1)

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Ulacia Flores P, Cieza T, Ouarrak S, Ruhl A, Mengi S, De Larochelliere R, Garcia-Labbe D, Dery JP, Poulin A, Larose E, Noel B, Nguyen CM, Paradis JM, Bertrand OF. Randomized Study Comparing Angiography Guidance With Physiology Guidance After PCI: The EASY-PREDICT Study. Circ Cardiovasc Interv. 2025 Jul;18(7):e015165. doi: 10.1161/CIRCINTERVENTIONS.125.015165. Epub 2025 May 21.

  PMID: 40400236 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable; Myocardial Ischemia; Chest Pain

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Olivier F. Bertrand, MD, PhD

  International Chair on Interventional Cardiology and Transradial Approach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 18, 2021
• Study Start: September 10, 2021
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)