Comparison of Double Kissing Culotte Stenting With Double Kissing Crush Stenting for True Bifurcation Lesions (no)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Fujian Medical University
Sponsor:
Collaborator:
R&G Pharma Studies Co.,Ltd.
Information provided by (Responsible Party):
Lianglong Chen, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT01735656
First received: November 9, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

Percutaneous coronary intervention (PCI) for the treatment of coronary bifurcation lesion (BL) remains a challenging task. The DK-crush have been established as a safe and efficacious dual-stenting technique, which can effectively improve the success rate of final kissing balloon inflation (FKBI) and reduce long-term major adverse cardiac events (MACE). However, in the clinical real world, especially when the bifurcation angle was relatively small, the DK-crush still has several limitations, such as kissing unsatisfied (KUS), relatively complex wiring or rewiring technique, incomplete stent coverage in the distal side of the side-branch ostium and near the carina, severe stent deformation or evenly acute stent destruction. Our observational study showed that the DK-culotte was also a safe and feasible dual-stenting technique and was equal to DK-crush in terms of improving FKBI and MACE. Nonetheless, there remain no studies for head-to-head comparison of clinical outcomes between the two approaches. We, thereby, carry out a multicentre, non-inferior, randomized and controlled trial to compare DK-culotte stenting versus DK-crush stenting in the treatment of true BL.


Condition Intervention
Coronary Heart Disease
Device: Resolute stents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Double Kissing Culotte Stenting With Double Kissing Crush Stenting in the Treatment of True Bifurcation Lesions: a Multicenter, Noninferior, Randomized, Controlled Trial (the DK Culotte-I Study)

Resource links provided by NLM:


Further study details as provided by Fujian Medical University:

Primary Outcome Measures:
  • Rate of target-lesion failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Rate of target-lesion failure, including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months after the procedure.


Secondary Outcome Measures:
  • Rate of target-lesion failure at 30 days,6 months and 24 months after the procedure. [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Rate of target-lesion failure, including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 30 days,6 months and 24 months after the procedure.

  • Rate of major adverse cardiac event(MACE)at 30 days,6 months,12 months and 24 months after the procedure. [ Time Frame: Immidiately to 24 months after procedure ] [ Designated as safety issue: Yes ]
    Major adverse cardiac event, including all caused death, nonfatal acute myocardial infarction, or any vessel revascularization at 30 days,6 months,12 months and 24 after the procedure.

  • Number of participants with in-stent thrombosis [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • NYHA functional class [ Time Frame: Immidiately to 24 months after procedure ] [ Designated as safety issue: Yes ]
  • Angina CCS classification [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Late lumen loss,in-stent and in-segment restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Late lumen loss,in-stent and in-segment restenosis which defined as angiographical primary outcome measure, in main vessel (MV) and side branch (SB) identified by angiography at 12th month after PCI

  • Elevation of myocardial markers (CK-MB, cTnT or cTnI) associated with the procedure baseline and 6, 12, or 12 hours after procedure [ Time Frame: Baseline and 6, 12, or 12 hours after procedure ] [ Designated as safety issue: Yes ]
    Elevation of myocardial markers (CK-MB, cTnT or cTnI) associated with the procedure baseline and 6, 12, or 12 hours after procedure

  • Braunwald classification [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Number of participants who experienced stroke [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Contrast volume used procedurally [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
  • Procedural time [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
  • Procedural X-ray exposure time [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
  • Procedural X-ray dosage [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
  • All-procedure, angiographic, and fluoroscopic dosage-area product (DAP) [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
  • Device consumption for the procedure [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]
    Device consumption is defined as the number and type of catheter, guidewire, balloon and stent used procedurally.

  • Guiding catheter size used [ Time Frame: 1 day (Immidiately after procedure) ] [ Designated as safety issue: No ]

Estimated Enrollment: 328
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DK-culotte & Resolute stents
Double kissing culotte technique for true bifurcation lesion with Resolute stents
Device: Resolute stents
zotarolimus-eluting Resolute stents made by Medtronic Vascular, Inc (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm294951.htm).
Other Name: zotarolimus-eluting stents
Active Comparator: DK-crush & Resolute stents
Double kissing crush technique for true bifurcation lesion with Resolute stents
Device: Resolute stents
zotarolimus-eluting Resolute stents made by Medtronic Vascular, Inc (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm294951.htm).
Other Name: zotarolimus-eluting stents

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with age of ≥18 and ≤80 years old.
  2. Patients with stable or unstable angina, or NSTEMI.
  3. De novo true bifurcation lesions (Medina 0,1,1/1,1,1/1,0,1); MV diameter ≥2.5mm and SB diameter ≥2.25.
  4. Lesions suitable for PCI (the SYNTAX score <32 if lesions located at LM bifurcation).
  5. Patients willing to receive all protocol-required evaluations.
  6. Patients completely understand the trial requirements and treatment procedures and provide written informed consent before any trial-specific tests or procedures are performed.

Exclusion Criteria:

  1. Patients with STEMI (within 24-hour from the onset of chest pain to admission).
  2. Lesions not suitable for PCI (the SYNTAX score ≥32 if lesions located at LM bifurcation, or any PCI-related contraindications including patient conditions and/or lesion characteristics).
  3. A Chronic total occlusion lesion involved in bifurcation
  4. Lesion with severe calcification that required for rotational atherectomy.
  5. Patients intolerable to long-term dual anti-platelet therapy.
  6. Patients with obvious hematopoietic disorders (e.g., platelet count< 100×10^9/L or >700×10^9/L, leukocyte count<3×10^9/L).
  7. Patients with active bleeding and obviously hemorrhagic tendency (e.g., active ulcer, recent ischemic stroke, previous hemorrhagic stroke, intracranial malignant tumors, recent craniocerebral trauma, or any other active bleeding or hemorrhagic tendency with difficult hemostasis
  8. Patients with serious renal insufficiency (Scr<30ml/min) or hepatic insufficiency (ALT≧3 times of normal upper limit), heart failure (NYHA class >III class).
  9. Patients with any other serious medical illness that life expectancy is less than 12 months.
  10. Woman with pregnancy or planning to pregnancy
  11. Patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
  12. Patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.
  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: NCT01735656

Contacts
Contact: Lianglong Chen, PHD, MD +86 139 5030 3022 lianglongchen@126.com

Locations
China, Fujian
Department of Cardiology, Union Hospital, Fujian Medical University Not yet recruiting
Fuzhou City, Fujian, China, 350001
Contact: Lianglong Chen, PhD, MD    (0086)139-5030-3022    lianglongchen@126.com   
Sponsors and Collaborators
Fujian Medical University
R&G Pharma Studies Co.,Ltd.
Investigators
Principal Investigator: Lianglong Chen, PhD, MD Union Hospital, Fujian Medical University
  More Information

No publications provided

Responsible Party: Lianglong Chen, Professor, PhD, MD, FACC, Fujian Medical University
ClinicalTrials.gov Identifier: NCT01735656     History of Changes
Other Study ID Numbers: the DK CULOTTE-I study
Study First Received: November 9, 2012
Last Updated: February 10, 2014
Health Authority: China: Ethics Committee

Keywords provided by Fujian Medical University:
Coronary heart disease;
Percutaneous coronary intervention;
Bifurcation lesion;
Double kissing culotte technique;
clinical trial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 10, 2014