Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05230446

PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

Led by Erasmus Medical Center · Updated on 2022-02-09

609

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).

CONDITIONS

Official Title

PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Candidate for drug-eluting stent treatment following PCI guidelines and manufacturer instructions
  • Target lesion characteristics meet Resolute Onyx stent system instructions for use
  • Willing and able to cooperate with study procedures and follow-up visits
  • Provided informed consent approved by ethics committee with data privacy authorization
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 85 years
  • Single coronary vessel disease
  • No lesion in left anterior descending artery
  • Cardiogenic shock
  • ST elevation myocardial infarction
  • Presence of chronic total occlusion lasting 3 months or more
  • Left main coronary artery disease
  • Unable to give informed consent or life expectancy less than 12 months
  • Allergies or contraindications to iodinated contrast, aspirin, or P2Y12 inhibitors
  • Extreme LAD tortuosity preventing OCT catheter advancement
  • Enrollment in another investigational device or drug trial not completed
  • Previous coronary artery bypass grafting
  • Need for cardiac surgery within 6 months
  • Women of childbearing potential without negative pregnancy test within 7 days, pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

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Research Team

R

Roberto Diletti, MD PhD

CONTACT

H

Hala Kakar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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