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

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03484234
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 36
• Locations: 2
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site: 18
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Stenosis	Device: Ultimaster stent; Device: Xience alpine stent	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jul 27, 2018
• Actual Primary Completion Date: Sep 6, 2019
• Actual Study Completion Date: Sep 6, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. In-segment late luminal loss [13-month]

Secondary Outcome Measures

1. All death [1 year]

2. Cardiac death [1 year]

3. Myocardial infarction (MI) [1 year]

4. Composite of death or MI [1 year]

5. Composite of cardiac death or MI [1 year]

6. Target vessel revascularization (ischemia-driven and clinically-driven) [1 year]

7. Target lesion revascularization (ischemia-driven and clinically-driven) [1 year]

8. Target-vessel failure [1 year]

   death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization

9. Stent thrombosis [1 year]

10. In-stent late loss [13-month]

    In-stent late loss at 13-month angiographic follow-up

11. In-stent and in-segment restenosis [13-month]

    In-stent and in-segment restenosis at 13-month angiographic follow-up

12. Angiographic pattern of restenosis [13-month]

    Angiographic pattern of restenosis at 13 -month angiographic follow-up

13. Volume of intimal hyperplasia [13-month]

    Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)

14. Incidence of late stent malapposition [13-month]

    Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)

15. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
2	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03484234
• Other Study ID Numbers: AMCCV2018-05
• First Posted: Mar 30, 2018
• Last Update Posted: Sep 10, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center: Drug eluting stent; everolimus eluting stent; sirolimus eluting stent
• Additional relevant MeSH terms: Coronary Artery Disease; Coronary Stenosis

Study Results

No Results Posted as of Sep 10, 2019