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Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

NCT03621501 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1525

Last updated 2022-11-08

No results posted yet for this study

Summary

To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI

Conditions

  • Acute Coronary Syndrome

Interventions

DEVICE

Percutaneous coronary intervention

At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).

Sponsors & Collaborators

Principal Investigators

  • Roberto Diletti, Dr. · Erasmus Medical Center

  • Nicolas Van Mieghem, Prof. · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2022-10-31
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621501 on ClinicalTrials.gov