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

A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Coronary Stenosis
• Intervention / Treatment: Device: Ultimaster stent; Device: Xience alpine stent

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultimaster stent	Device: Ultimaster stent; Percutaneous coronary intervention with Ultimaster stent for long lesion
Active Comparator: Xience alpine stent	Device: Xience alpine stent; Percutaneous coronary intervention with Xience alpine stent for long lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment late luminal loss	13-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		1 year
Composite of death or MI		1 year
Composite of cardiac death or MI		1 year
All death		1 year
Myocardial infarction (MI)		1 year
Target vessel revascularization (ischemia-driven and clinically-driven)		1 year
Target lesion revascularization (ischemia-driven and clinically-driven)		1 year
Target-vessel failure	death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization	1 year
Stent thrombosis		1 year
In-stent late loss	In-stent late loss at 13-month angiographic follow-up	13-month
In-stent and in-segment restenosis	In-stent and in-segment restenosis at 13-month angiographic follow-up	13-month
Angiographic pattern of restenosis	Angiographic pattern of restenosis at 13 -month angiographic follow-up	13-month
Volume of intimal hyperplasia	Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)	13-month
Incidence of late stent malapposition	Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)	13-month
Procedural success	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.	5 days

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 8, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Drug eluting stent; everolimus eluting stent; sirolimus eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: AMCCV2018-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No