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Coronary Artery DiseasePhase 4PERFECTNCT00693251

Optimal Stenting Strategy For True Bifurcation Lesions

A Phase 4 study testing Crush technique and provisional T stenting in people with Coronary Artery Disease, run by Seung-Jung Park at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Crush technique and provisional T stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
12 sitesSouth Korea
Study dates
Jan 2008to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 14Show fewer
  • 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%

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si

  • Busan Saint Mary's Hospital

    Busan

  • Cheongju Saint Mary's Hospital

    Cheongju-si

  • Kangwon University Hospital

    Chuncheon

  • Chungnam National University Hospital

    Daejeon

  • Kyungsang University Hospital

    Jinju

  • Hallym University Sacred Heart Hospital

    Pyeongchon

  • Catholic University, Kangnam St. Mary's Hospital

    Seoul

  • Hallym University Sacred Heart Hospital

    Seoul

  • Korea Veterans Hospital

    Seoul

  • Aju University Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

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.

Being tested
Crush technique, provisional T stenting
Keywords
stent, bifurcation, coronary artery stenosis, balloon angioplasty
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crush techniqueProcedure or surgery

    Also called Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

    Crush technique

  • provisional T stentingProcedure or surgery

    Also called Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

    Provisional T stenting

Study groups in NCT00693251
Study groupRoleWhat they receive
bifurcation stent techniqueExperimentalcrush technique
Receives: Procedure: Crush technique
bifurcation stent techniqeActive comparatorprovisional T stenting
Receives: Procedure: provisional T stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 months

Secondary outcomes (11)

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

    Measured: 2 years

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

    Measured: 8 months

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

    Measured: 8 months

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

    Measured: 8 months

  5. Influence of bifurcation angle

    Measured: 8 months

  6. Influence of new three segment bifurcation QCA software

    Measured: 8 months

  7. Fluoroscopic time

    Measured: baseline

  8. Procedure time

    Measured: baseline

  9. Amount of contrast agent

    Measured: baseline

  10. Number of used stents

    Measured: baseline

  11. FFR assessment in the side branch

    Measured: baseline and 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00693251
Sponsor's protocol ID
2007-0714
Acronym
PERFECT
Status last verified
Nov 2015
First submitted
5 Jun 2008
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Crush technique and provisional T stenting in people with Coronary Artery Disease, run by Seung-Jung Park at 12 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00693251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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