Skip to content

Optimal Stenting Strategy For True Bifurcation Lesions

Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00693251
Acronym
PERFECT
Enrollment
420
Registered
2008-06-09
Start date
2008-01-31
Completion date
2015-06-30
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

stent, bifurcation, coronary artery stenosis, balloon angioplasty

Brief summary

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

Detailed 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.

Interventions

Crush technique

PROCEDUREprovisional T stenting

Provisional T stenting

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Seung-Jung Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frame
Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch8 months

Secondary

MeasureTime frame
Reocclusion rate at the side branch at 8 month angiographic follow-up8 months
Late loss at the main vessel and the side branch8 months
Restenosis rate at the main vessel and/or side branch8 months
Influence of bifurcation angle8 months
Influence of new three segment bifurcation QCA software8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization2 years
Procedure timebaseline
Amount of contrast agentbaseline
Number of used stentsbaseline
FFR assessment in the side branchbaseline and 8 months
Fluoroscopic timebaseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026