Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers

N/ANot Yet RecruitingNCT07566091

Jung-min Ahn2,034 enrolled

Overview

The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,034

Conditions

Coronary Artery Disease

Interventions

Sirolimus-Ascorbic Acid Eluting StentDEVICE

bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent

Everolimus-Eluting StentDEVICE

bioabsorbable polymer everolimus-eluting stent

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult men and women aged 19 years or older 2. Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers) 3. Patients who have voluntarily provided written informed consent to participate in the study Exclusion Criteria: 1. Cardiogenic shock within 48 hours prior to the procedure 2. Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy) 3. Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year 4. Women who are pregnant, breastfeeding, or of childbearing potential 5. Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study 6. Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol 7. Patients who are unwilling or unable to comply with the study protocol

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The event rate of Target Lesion Failure

Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.

Time frame: 1 year

Secondary Outcomes

The event rate of Device success

Acute Success Endpoints\_lesion level

Time frame: 1 year

The event rate of Procedural success

Acute Success Endpoints\_patient level

Time frame: 1 year

The event rate of Death from any causes

Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

Time frame: 1 year

The event rate of Any stroke

Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

Time frame: 1 year

The event rate of Any myocardial infarction

Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

Time frame: 1 year

The event rate of Any repeat revascularization

Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

Time frame: 1 year

The event rate of Cardiovascular death

Major Composite Clinical Endpoints\_Target Vessel Failure

Time frame: 1 year

Central Contacts

Jung-hee Ham Project Manager, Registered Nurse

CONTACT

82-2-3010-4728 cvcrc5@amc.seoul.kr

Data from ClinicalTrials.gov

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