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

S

Seung-Jung Park

Status

Terminated

Conditions

Coronary Artery Disease
Coronary Stenosis

Treatments

Device: Ultimaster stent
Device: Xience alpine stent

Study type

Interventional

Funder types

Other

Identifiers

NCT03484234
AMCCV2018-05

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Ultimaster stent
Experimental group
Treatment:
Device: Ultimaster stent
Xience alpine stent
Active Comparator group
Treatment:
Device: Xience alpine stent

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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