Optimal Stenting Strategy For True Bifurcation Lesions

Coronary Artery Disease Clinical Trial

— PERFECT  

Official title:

Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693251
• Other study ID #: 2007-0714
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2008
• Last updated: November 16, 2015
• Start date: January 2008
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Description:

The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events compared with non-bifurcated lesions.1 Randomized studies have demonstrated that drug-eluting stents reduce restenosis when used in relatively simple lesions; and recent data have demonstrated efficacy of the sirolimus-eluting stent for bifurcation lesions compared with historical data of BMS. In one study of bifurcation lesions, the overall restenosis rate was 23%, with the majority of side branch restenoses occurring at the ostium after use of a T-stenting technique. Indeed, side branch restenosis occurred in 16.7% after T-stenting, compared with 7.1% after other stenting techniques.

The "crush" technique of bifurcation stenting with DESs was introduced by Colombo et al. in 2003 as a relatively simple technique that ensures complete coverage of the side branch ostium, thereby facilitating drug delivery at this site. Initial data of 20 patients treated with this technique with SES suggest that it is a safe method, with an acceptable rate of procedural complications and no further adverse events up to 30 days follow-up. Recently, angiographic data have shown the importance of simultaneous kissing balloon post-dilation in reducing restenosis and need for target lesion revascularization. They also reported that compared to T-stenting, crushing with final kissing balloon dilatation was associated with lower rate of restenosis and target lesion revascularization. Consequently, the crushing is currently most promising technique in treating bifurcation lesions using two stents. However, despite the advance of bifurcation stenting technique, the superiority of bifurcation stenting with crushing technique over simple stenting in bifurcation lesion has not been demonstrated.

Therefore, we conducted the prospective randomized study comparing crushing technique with final kissing balloon dilatation and a simple technique (main vessel stenting and provisional T-stenting) for treatment of true bifurcation lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 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

Exclusion Criteria:

• 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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Crush technique
Crush technique
• provisional T stenting
Provisional T stenting

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Busan Saint Mary's Hospital	Busan
Korea, Republic of	Cheongju Saint Mary's Hospital	Cheongju
Korea, Republic of	Kangwon University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Kyungsang University Hospital	Jinju
Korea, Republic of	Hallym University Sacred Heart Hospital	PyeongChon
Korea, Republic of	Catholic University, Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Hallym University Sacred Heart Hospital	Seoul
Korea, Republic of	Korea Veterans Hospital	Seoul
Korea, Republic of	Aju University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch		8 months	No
Secondary	Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization		2 years	Yes
Secondary	Reocclusion rate at the side branch at 8 month angiographic follow-up		8 months	No
Secondary	Late loss at the main vessel and the side branch		8 months	No
Secondary	Restenosis rate at the main vessel and/or side branch		8 months	No
Secondary	Influence of bifurcation angle		8 months	No
Secondary	Influence of new three segment bifurcation QCA software		8 months	No
Secondary	Fluoroscopic time		baseline	No
Secondary	Procedure time		baseline	No
Secondary	Amount of contrast agent		baseline	No
Secondary	Number of used stents		baseline	No
Secondary	FFR assessment in the side branch		baseline and 8 months	No