Optimal Stenting Strategy For True Bifurcation Lesions (PERFECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00693251
First received: June 5, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Procedure: Crush technique
Procedure: provisional T stenting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Reocclusion rate at the side branch at 8 month angiographic follow-up [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Late loss at the main vessel and the side branch [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Restenosis rate at the main vessel and/or side branch [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Influence of bifurcation angle [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Influence of new three segment bifurcation QCA software [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Fluoroscopic time [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Amount of contrast agent [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Number of used stents [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • FFR assessment in the side branch [ Time Frame: baseline and 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bifurcation stent technique
crush technique
Procedure: Crush technique
Crush technique
Other Name: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
Active Comparator: bifurcation stent techniqe
provisional T stenting
Procedure: provisional T stenting
Provisional T stenting
Other Name: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693251

Locations
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
Korea Veterans Hospital
Seoul, Korea, Republic of
Catholic University, Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
Seoul, Korea, Republic of
Aju University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00693251     History of Changes
Other Study ID Numbers: 2007-0714
Study First Received: June 5, 2008
Last Updated: August 20, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
stent
bifurcation
coronary artery stenosis
balloon angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Paclitaxel
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014