Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

NCT03484234 | Terminated DMC

• 1 other identifier: AMCCV2018-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.

Conditions

Coronary Artery Disease; Coronary Stenosis

Keywords

Drug eluting stent; everolimus eluting stent; sirolimus eluting stent

Outcome Measures

Primary Outcomes (1)

• In-segment late luminal loss

  13-month

Secondary Outcomes (15)

• All death

  1 year

• Cardiac death

  1 year

• Myocardial infarction (MI)

  1 year

• Composite of death or MI

  1 year

• Composite of cardiac death or MI

  1 year

Study Arms (2)

Ultimaster stent

EXPERIMENTAL

Device: Ultimaster stent

Xience alpine stent

ACTIVE COMPARATOR

Device: Xience alpine stent

Interventions

Ultimaster stent DEVICE

Percutaneous coronary intervention with Ultimaster stent for long lesion

Ultimaster stent

Xience alpine stent DEVICE

Percutaneous coronary intervention with Xience alpine stent for long lesion

Xience alpine stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be at least 19 years of age.
• Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
• Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

• Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
• Acute ST-segment-elevation MI or cardiogenic shock
• Terminal illness with life expectancy \<1 year
• In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
• Patients with EF\<30%.
• Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
• Patients with left main stem stenosis (\>50% by visual estimate)

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (2)

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Division of Cardiology

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 30, 2018
• Study Start: July 27, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

KR (2)