search
Back to results

LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
percutaneous coronary intervention
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 long lesions, drug eluting stents

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age more than 20 years
  • Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
  • Patients with silent ischemia, stable or unstable angina pectoris, and 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, zotarolimus, 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
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted
  • Patients with EF < 30%
  • Serum creatinine level >=2.0mg/dL or dependence on dialysis
  • Patients with left main stem stenosis (> 50% visual estimate)

Sites / Locations

  • Gangwon National Univ. Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National university hospital
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
  • Chonnam National University Hospital
  • National Health Insurance Service Ilsan Hospital
  • Korea University Guro Hospital
  • Kyunghee University Medical Center
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • St.carollo Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

zotarolimus-eluting stent

everolimus-eluting stent

Arm Description

Resolute Integrity or Resolute Onyx stent

Xience Prime or Xience Xpedition or Xience Alpine stent

Outcomes

Primary Outcome Measures

In-segment late luminal loss at 13 month follow-up

Secondary Outcome Measures

1. All Death
2. Cardiac death
3. Myocardial infarction (MI)
4. Composite of death or MI
5. Composite of cardiac death or MI
6. Target vessel revascularization (ischemia-driven and clinically-driven)
7. Target lesion revascularization (ischemia-driven and clinically-driven)
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
9. Stent thrombosis (ARC criteria)
10. In-stent late loss
11. In-stent and in-segment restenosis
12. Angiographic pattern of restenosis
13. Volume of intimal hyperplasia
sub-study
14. Incidence of late stent malapposition
sub-study
15. 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
December 8, 2011
Last Updated
February 23, 2017
Sponsor
Seung-Jung Park
Collaborators
Abbott, CardioVascular Research Foundation, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01489761
Brief Title
LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)
Official Title
Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
February 14, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
Detailed Description
Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
long lesions, drug eluting stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zotarolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Resolute Integrity or Resolute Onyx stent
Arm Title
everolimus-eluting stent
Arm Type
Experimental
Arm Description
Xience Prime or Xience Xpedition or Xience Alpine stent
Intervention Type
Device
Intervention Name(s)
percutaneous coronary intervention
Other Intervention Name(s)
Resolute Integrity or Resolute Onyx stent, Xience Prime or Xience Xpedition or Xience Alpine stent
Intervention Description
drug eluting stent implantation
Primary Outcome Measure Information:
Title
In-segment late luminal loss at 13 month follow-up
Time Frame
13 month post stenting
Secondary Outcome Measure Information:
Title
1. All Death
Time Frame
12 month clinical follow-up
Title
2. Cardiac death
Time Frame
12 month clinical follow-up
Title
3. Myocardial infarction (MI)
Time Frame
12 month clinical follow-up
Title
4. Composite of death or MI
Time Frame
12 month clinical follow-up
Title
5. Composite of cardiac death or MI
Time Frame
12 month clinical follow-up
Title
6. Target vessel revascularization (ischemia-driven and clinically-driven)
Time Frame
12 month clinical follow-up
Title
7. Target lesion revascularization (ischemia-driven and clinically-driven)
Time Frame
12 month clinical follow-up
Title
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Time Frame
12 month clinical follow-up
Title
9. Stent thrombosis (ARC criteria)
Time Frame
12 month clinical follow-up
Title
10. In-stent late loss
Time Frame
13 month angiographic follow-up
Title
11. In-stent and in-segment restenosis
Time Frame
13 month angiographic follow-up
Title
12. Angiographic pattern of restenosis
Time Frame
13 month angiographic follow-up
Title
13. Volume of intimal hyperplasia
Description
sub-study
Time Frame
13 month IVUS follow-up
Title
14. Incidence of late stent malapposition
Description
sub-study
Time Frame
13 month IVUS follow-up
Title
15. 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
2-3 days post stenting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age more than 20 years Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment Patients with silent ischemia, stable or unstable angina pectoris, and 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, zotarolimus, 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 Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted Patients with EF < 30% Serum creatinine level >=2.0mg/dL or dependence on dialysis Patients with left main stem stenosis (> 50% visual estimate)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National university hospital
City
Daegu
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon ST. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St.carollo Hospital
City
Suncheon
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.

Learn more about this trial

LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

We'll reach out to this number within 24 hrs