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Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions (LONG-DES-V)

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186120
First received: August 18, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.


Condition Intervention Phase
Coronary Artery Disease
 Device: Biolimus A9-eluting stent
Device: Everolimus-eluting stent
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • In-segment late luminal loss [ Time Frame: 9 month angiographic follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death (all-cause and cardiac) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • stent thrombosis(ARC criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • target-lesion revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • target-vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: at 1 day ] [ Designated as safety issue: No ]
  • Death (all-cause and cardiac) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Death (all-cause and cardiac) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • target-lesion revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • target-lesion revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • target-vessel revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • target-vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • stent thrombosis(ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • stent thrombosis(ARC criteria) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • In-stent late loss [ Time Frame: 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment restenosis [ Time Frame: 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Angiographic pattern of restenosis [ Time Frame: 9 month angiographic follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biolimus A9-eluting stent
NOBORI stent
 Device: Biolimus A9-eluting stent
drug-eluting stent
Other Name: NOBORI stent
Active Comparator: Everolimus-eluting stent
PROMUS ELEMENTE stent
 Device: Everolimus-eluting stent
drug-eluting stent
Other Name: PROMUS ELEMENT stent

Detailed Description:

Following angiography, patients with significant diameter stenosis >50% and lesion length(> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age.
  • Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
  • Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
  • 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
  • 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, non-target vessel ISR is permitted) Patients with EF<30%.
  • Serum creatinine level >=3.0mg/dL or dependence on dialysis.
  • Patients with left main stem stenosis (>50% by visual estimate).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186120

Contacts
Contact: Seung-Jung Park, MD, PhD 2-3010-4812 ext 82 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 2-3010-3995 ext 82 dwpark@amc.seoul.kr

Locations
Korea, Republic of
Soonchunhyang University Hospital, Buchen Recruiting
Bucheon, Korea, Republic of
Contact: Nae Hee Lee            
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Won-Yong Shin, MD            
Principal Investigator: Won-Yong Shin, MD            
Kangwon National University Hospital Recruiting
Chooncheon, Korea, Republic of
Contact: Bong-Ki Lee            
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Seung Ho Her            
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD, PhD            
Principal Investigator: Kee-Sik Kim, MD, PhD            
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Hun Sik Park            
NHIC Ilsan Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joo-Joung Yang, MD, PhD            
Principal Investigator: Joo-Young Yang, MD, PhD            
Inje University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae-Hyun Yang            
Dong-A University Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Moo Hyun Kim            
Catholic University, Kangnam St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Bae Seung, MD         kbseung@catholic.ac.kr    
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park Park, MD, PhD     (82-2)-3010-4812     sjpark@amc.seoul.kr    
Contact: Duk-Wo Park, MD, PhD            
Principal Investigator: Seung-Jung Park,, MD, PhD            
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD.,PhD. Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01186120     History of Changes
Other Study ID Numbers: 2010-0036
Study First Received: August 18, 2010
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013