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CompletedNCT00693251PERFECTUpdated Nov 17, 2015

Optimal Stenting Strategy For True Bifurcation Lesions

A Phase 4 interventional study of Crush technique and provisional T stenting in Coronary Artery Disease, sponsored by Seung-Jung Park. Completed at 12 sites in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-17.

Sponsored by Seung-Jung Park · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • stent
  • bifurcation
  • coronary artery stenosis
  • balloon angioplasty
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 420 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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%
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
420 participants (actual)

Study arms

  • Experimental
    bifurcation stent technique

    crush technique

    Procedure: Crush technique

  • Active comparator
    bifurcation stent techniqe

    provisional T stenting

    Procedure: provisional T stenting

Interventions

  • ProcedureCrush technique

    Crush technique

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

  • Procedureprovisional T stenting

    Provisional T stenting

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

06

What researchers measure

Primary outcomes

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

    Time frame: 8 months

Secondary outcomes

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

    Time frame: 2 years

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

    Time frame: 8 months

  3. Late loss at the main vessel and the side branch

    Time frame: 8 months

  4. Restenosis rate at the main vessel and/or side branch

    Time frame: 8 months

  5. Influence of bifurcation angle

    Time frame: 8 months

  6. Influence of new three segment bifurcation QCA software

    Time frame: 8 months

  7. Fluoroscopic time

    Time frame: baseline

  8. Procedure time

    Time frame: baseline

  9. Amount of contrast agent

    Time frame: baseline

  10. Number of used stents

    Time frame: baseline

  11. FFR assessment in the side branch

    Time frame: baseline and 8 months

07

Study locations

12 sites
  • Soonchunhyang University Bucheon Hospital
    Bucheon-si, South Korea
  • Busan Saint Mary's Hospital
    Busan, South Korea
  • Cheongju Saint Mary's Hospital
    Cheongju-si, South Korea
  • Kangwon University Hospital
    Chuncheon, South Korea
  • Chungnam National University Hospital
    Daejeon, South Korea
  • Kyungsang University Hospital
    Jinju, South Korea
  • Hallym University Sacred Heart Hospital
    Pyeongchon, South Korea
  • Catholic University, Kangnam St. Mary's Hospital
    Seoul, South Korea
  • Hallym University Sacred Heart Hospital
    Seoul, South Korea
  • Korea Veterans Hospital
    Seoul, South Korea
  • Aju University Hospital
    Suwon, South Korea
  • Ulsan University Hospital
    Ulsan, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2008
First posted
Jun 9, 2008
Start
Jan 2008
Primary completionActual
Jun 2015
CompletionActual
Jun 2015
Last update
Nov 17, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693251
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea) — Sponsor-investigator
First posted
Jun 9, 2008
Start date
Jan 2008
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Nov 17, 2015

Study contacts

Seung-Jung Park, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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