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

NCT05230446 | Recruiting

• 1 other identifier: NL76556.078.21
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multi Vessel Coronary Artery Disease; Non-ST Elevation Myocardial Infarction; Unstable Angina; Stable Angina; Coronary Artery Disease; Percutaneous Coronary Intervention; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• MACCE- 1 year

  The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.

  1 year

Secondary Outcomes (7)

• MACCE

  30 days, 2, and 5 years post intervention

• All-cause mortality

  30 days, 1, 2, and 5 years

• Myocardial Infarction

  30 days, 1, 2, and 5 years

• Any revascularization

  30 days, 1, 2, and 5 years

• Stroke

  30 days, 1, 2, and 5 years

Study Arms (1)

Percutaneous Coronary Intervention

OTHER

Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results

Device: PCI with OCT guidance

Interventions

PCI with OCT guidance DEVICE

Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.

Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, ≤85 years
• The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
• Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.
• The patient is willing and able to cooperate with study procedures and required follow up visits
• The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

You may not qualify if:

• Age \<18 years and \> 85 years.
• Single coronary vessel disease.
• No left anterior descending lesion.
• Patients in cardiogenic shock.
• Patients with STEMI.
• Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months.
• Left main coronary artery disease
• Patients who cannot give informed consent or have a life expectancy of less than 12 months.
• Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
• Patients with an extreme LAD tortuosity imparing OCT catheter advancement
• Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint. The patient may only be enrolled once in the PRESENT study.
• Previous coronary artery bypass grafting (CABG).
• Patient requiring additional cardiac surgery within 6 months.
• Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Angina, Unstable; Angina, Stable; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Roberto Diletti, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Diletti, MD PhD

CONTACT

+31 (0)10 70 352 60; r.diletti@erasmusmc.nl

Hala Kakar, MD

CONTACT

h.kakar.1@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: February 9, 2022
• Study Start: November 18, 2021
• Primary Completion: November 18, 2023
• Study Completion (Estimated): November 18, 2027
• Last Updated: February 9, 2022

Record last verified: 2022-01

Locations

NL (1)