Optimal Stenting Strategy For True Bifurcation Lesions

NCT00693251 | Completed Phase 4 DMC

• 1 other identifier: 2007-0714
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 12

Brief Summary

It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.

Conditions

Coronary Artery Disease

Keywords

stent; bifurcation; coronary artery stenosis; balloon angioplasty

Outcome Measures

Primary Outcomes (1)

• Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch

  8 months

Secondary Outcomes (11)

• Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization

  2 years

• Reocclusion rate at the side branch at 8 month angiographic follow-up

  8 months

• Late loss at the main vessel and the side branch

  8 months

• Restenosis rate at the main vessel and/or side branch

  8 months

• Influence of bifurcation angle

  8 months

Study Arms (2)

bifurcation stent technique

EXPERIMENTAL

crush technique

Procedure: Crush technique

bifurcation stent techniqe

ACTIVE COMPARATOR

provisional T stenting

Procedure: provisional T stenting

Interventions

Crush technique PROCEDURE

Crush technique

Also known as: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

bifurcation stent technique

provisional T stenting PROCEDURE

Provisional T stenting

Also known as: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

bifurcation stent techniqe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical
• Patients with angina and documented ischemia or patients with documented silent ischemia
• Patients who are eligible for intracoronary stenting
• Age \>18 years, \<75 ages
• Angiographic
• De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
• Main vessel : \>= 2.5 mm in vessel size, \>= 50% in diameter stenosis and =\< 50 mm in lesion length by visual estimation, in which the lesion seems to be covered with =\< 2 stents
• Side branch : \>= 2.0 mm in vessel size, \>= 50% in diameter stenosis, and \< 20 mm in lesion length by visual estimation, in which the lesion seems to be covered with single stent

You may not qualify if:

• History of bleeding diathesis or coagulopathy
• Pregnant
• Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
• Limited life-expectancy (less than 1 year) due to combined serious disease
• ST-elevation acute myocardial infarction \< 2 weeks
• Characteristics of lesion:
• Left main disease
• In-stent restenosis
• Graft vessels
• Chronic total occlusion
• TIMI flow =\< grade 2 in the side branch
• Renal dysfunction, creatinine \>= 2.0mg/dL
• Contraindication to aspirin, clopidogrel or cilostazol
• LV ejection fraction =\< 35%

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (12)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Busan Saint Mary's Hospital

Busan, South Korea

Location

Cheongju Saint Mary's Hospital

Cheongju-si, South Korea

Location

Kangwon University Hospital

Chuncheon, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Kyungsang University Hospital

Jinju, South Korea

Location

Hallym University Sacred Heart Hospital

Pyeongchon, South Korea

Location

Catholic University, Kangnam St. Mary's Hospital

Seoul, South Korea

Location

Hallym University Sacred Heart Hospital

Seoul, South Korea

Location

Korea Veterans Hospital

Seoul, South Korea

Location

Aju University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Sirolimus; Paclitaxel; zotarolimus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

KR (12)