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Comparison of Double Kissing Culotte Stenting With Double Kissing Crush Stenting for True Bifurcation Lesions

NCT01735656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2022-09-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Resolute stents

zotarolimus-eluting Resolute stents made by Medtronic Vascular, Inc (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm294951.htm).

Sponsors & Collaborators

  • Jetmed（Beijing）Co.,Ltd.

    collaborator UNKNOWN

  • Fujian Medical University

    lead OTHER

Principal Investigators

  • Lianglong Chen, PhD, MD · Union Hospital, Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-12-31
Completion
2021-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735656 on ClinicalTrials.gov