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

ConditionCoronary Artery Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorJung-min Ahn

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women aged 19 years or older

Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)

Patients who have voluntarily provided written informed consent to participate in the study

Disqualifiers

Cardiogenic shock within 48 hours prior to the procedure

Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)

Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year

Have not confirmed a negative pregnancy test prior to enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

Sirolimus-Ascorbic Acid Eluting Stent
Device
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
Everolimus-Eluting Stent
Device
bioabsorbable polymer everolimus-eluting stent

Treatment groups

2,034 Participants

are divided into 2 treatment groups

Group A: Sirolimus-Ascorbic Acid Eluting StentExperimental treatment 1 intervention

Group B: Everolimus-Eluting StentActive comparator 1 intervention

Trial 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

Other outcomes

The event rate of Definite or probable stent thrombosis

Safety Endpoints

Time frame

1 year

The event rate of Definite stent thrombosis

Safety Endpoints

Time frame

1 year

The event rate of Probable stent thrombosis

Safety Endpoints

Time frame

1 year

The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5

Safety Endpoints

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jung-min Ahn

Lead sponsor

Asan Medical Center

Sponsor institution

The CardioVascular Research Foundation (CVRF)

Collaborator

Source ClinicalTrials.gov

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