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

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Coronary Stenosis
• Interventions: Device: Ultimaster stent; Device: Xience alpine stent

• Registration Number: NCT03484234
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-30
• Study Start: 2018-07-27
• Status Verified: 2019-09
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Last Update Submitted: 2019-09-08
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. The patient must be at least 19 years of age.
2. 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.
3. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
4. 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultimaster stent	Ultimaster stent	-
Xience alpine stent	Xience alpine stent	-

Primary Outcome Measures

Name	Time	Method
In-segment late luminal loss	13-month

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization (ischemia-driven and clinically-driven)	1 year
Target-vessel failure	1 year	death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
All death	1 year
Composite of death or MI	1 year
In-stent late loss	13-month	In-stent late loss at 13-month angiographic follow-up
Stent thrombosis	1 year
Volume of intimal hyperplasia	13-month	Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)
Myocardial infarction (MI)	1 year
In-stent and in-segment restenosis	13-month	In-stent and in-segment restenosis at 13-month angiographic follow-up
Angiographic pattern of restenosis	13-month	Angiographic pattern of restenosis at 13 -month angiographic follow-up
Cardiac death	1 year
Composite of cardiac death or MI	1 year
Target lesion revascularization (ischemia-driven and clinically-driven)	1 year
Incidence of late stent malapposition	13-month	Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)
Procedural success	5 days	Procedural success defined as achievement of a final diameter stenosis of \<30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of