Clinical trial NCT00694005: Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
Official title: Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: stent
bifurcation
balloon angioplasty
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2008-06-09
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Detailed description: Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size \>2.0 mm. DS\>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.

Eligibility criteria: Inclusion Criteria:

* 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 is covered with =\< 2 stents
  * Side branch :\>= 2.0 mm in vessel size and \< 50% diameter stenosis by visual estimation

Exclusion Criteria:

* History of bleeding diathesis or coagulopathy
* Pregnant
* Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
* 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
  * TIMI flow =\< grade 2 in the side branch
  * Chronic total occlusion
* Renal dysfunction, creatinine \>= 2.0mg/dL
* Contraindication to aspirin, clopidogrel or cilostazol

Primary outcomes:
measure: Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
timeFrame: 8 months
Secondary outcomes:
measure: Incidence of side branch jail after main vessel stenting according to the stent type used
timeFrame: Day 1
measure: Angiographic reocclusion rate of side branch
timeFrame: 8 months
measure: Angiographic restenosis rate of side branch and the main vessel
timeFrame: 8 months
measure: Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
timeFrame: 8 months
measure: Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
timeFrame: 8 months
measure: Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
timeFrame: 8 months
measure: Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
timeFrame: 2 years
measure: FFR of the side branch at post-procedure and at follow-up
timeFrame: Day 1, 8 months
measure: Incidence of peri-procedural cardiac enzyme elevation
timeFrame: Day 1
measure: Fluoroscopic time
timeFrame: Day 1
measure: Procedure time
timeFrame: Day 1
measure: Amount of contrast agent
timeFrame: Day 1
measure: Number of used stents
timeFrame: Day 1
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Saint Mary's Hospital
city: Cheongju
country: Korea, Republic of
facility: Cheongju Saint Mary's Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Jinju
country: Korea, Republic of
facility: Kyungsang University Hospital
city: PyeongChon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University, Kangnam St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Suwon
country: Korea, Republic of
facility: Aju University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Kangwon University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: