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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)

Primary Purpose

Coronary Artery Disease, Coronary Stenosis

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultimaster stent
Xience alpine stent
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug eluting stent, everolimus eluting stent, sirolimus eluting stent

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Gangwon National Univ. Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultimaster stent

Xience alpine stent

Arm Description

Outcomes

Primary Outcome Measures

In-segment late luminal loss

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2018
Last Updated
September 8, 2019
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03484234
Brief Title
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
At sponsor's discretion : The purpose of study is no longer maintained
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
September 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Stenosis
Keywords
Drug eluting stent, everolimus eluting stent, sirolimus eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultimaster stent
Arm Type
Experimental
Arm Title
Xience alpine stent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ultimaster stent
Intervention Description
Percutaneous coronary intervention with Ultimaster stent for long lesion
Intervention Type
Device
Intervention Name(s)
Xience alpine stent
Intervention Description
Percutaneous coronary intervention with Xience alpine stent for long lesion
Primary Outcome Measure Information:
Title
In-segment late luminal loss
Time Frame
13-month
Secondary Outcome Measure Information:
Title
All death
Time Frame
1 year
Title
Cardiac death
Time Frame
1 year
Title
Myocardial infarction (MI)
Time Frame
1 year
Title
Composite of death or MI
Time Frame
1 year
Title
Composite of cardiac death or MI
Time Frame
1 year
Title
Target vessel revascularization (ischemia-driven and clinically-driven)
Time Frame
1 year
Title
Target lesion revascularization (ischemia-driven and clinically-driven)
Time Frame
1 year
Title
Target-vessel failure
Description
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Time Frame
1 year
Title
Stent thrombosis
Time Frame
1 year
Title
In-stent late loss
Description
In-stent late loss at 13-month angiographic follow-up
Time Frame
13-month
Title
In-stent and in-segment restenosis
Description
In-stent and in-segment restenosis at 13-month angiographic follow-up
Time Frame
13-month
Title
Angiographic pattern of restenosis
Description
Angiographic pattern of restenosis at 13 -month angiographic follow-up
Time Frame
13-month
Title
Volume of intimal hyperplasia
Description
Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)
Time Frame
13-month
Title
Incidence of late stent malapposition
Description
Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)
Time Frame
13-month
Title
Procedural success
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must be at least 19 years of age. 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. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI) 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: Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment. Acute ST-segment-elevation MI or cardiogenic shock Terminal illness with life expectancy <1 year In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted. Patients with EF<30%. Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis. Patients with left main stem stenosis (>50% by visual estimate)
Facility Information:
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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