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

Coronary Artery Disease Clinical Trial

— LONG-DES VII  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03484234
• Other study ID #: AMCCV2018-05
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: September 6, 2019

Study information

• Verified date: September 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis

Intervention

Device:
• Ultimaster stent
Percutaneous coronary intervention with Ultimaster stent for long lesion
• Xience alpine stent
Percutaneous coronary intervention with Xience alpine stent for long lesion

Locations

Country	Name	City	State
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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