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

NCT01735656 | Completed DMC

• 1 other identifier: the DK CULOTTE-I study
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 12

Brief 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

Coronary Heart Disease

Keywords

Coronary heart disease;; Percutaneous coronary intervention;; Bifurcation lesion;; Double kissing culotte technique;; clinical trial

Outcome Measures

Primary Outcomes (1)

• Rate of target-lesion failure

  Rate of target-lesion failure, including cardiac death, target-vessel myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months after the procedure.

  12 months

Secondary Outcomes (8)

• Rate of target-lesion failure at 30 days,6 months and 24 months after the procedure.

  Up to 2 years

• Rate of major adverse cardiac event(MACE）at 30 days，6 months，12 months and 24 months after the procedure.

  Immidiately to 24 months after procedure

• Number of participants with in-stent thrombosis

  Up to 2 years

• NYHA functional class

  Immidiately to 24 months after procedure

• Angina CCS classification

  Up to 2 years

Other Outcomes (8)

• Number of participants who experienced stroke

  up to 2 years

• Contrast volume used procedurally

  1 day (Immidiately after procedure)

• Procedural time

  1 day (Immidiately after procedure)

Study Arms (2)

DK-culotte & Resolute stents

EXPERIMENTAL

Double kissing culotte technique for true bifurcation lesion with Resolute stents

Device: Resolute stents

DK-crush & Resolute stents

ACTIVE COMPARATOR

Double kissing crush technique for true bifurcation lesion with Resolute stents

Device: Resolute stents

Interventions

Resolute stents DEVICE

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

Also known as: zotarolimus-eluting stents

DK-crush & Resolute stents; DK-culotte & Resolute stents

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with STEMI (within 24-hour from the onset of chest pain to admission).
• 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).
• A Chronic total occlusion lesion involved in bifurcation
• Lesion with severe calcification that required for rotational atherectomy.
• Patients intolerable to long-term dual anti-platelet therapy.
• Patients with obvious hematopoietic disorders (e.g., platelet count\< 100×10\^9/L or \>700×10\^9/L, leukocyte count\<3×10\^9/L).
• 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
• Patients with serious renal insufficiency (Scr\<30ml/min) or hepatic insufficiency (ALT≧3 times of normal upper limit), heart failure (NYHA class \>III class).
• Patients with any other serious medical illness that life expectancy is less than 12 months.
• Woman with pregnancy or planning to pregnancy
• Patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
• Patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.

Sponsors & Collaborators

• Fujian Medical University: lead
• Jetmed（Beijing）Co.,Ltd.: collaborator

Study Sites (12)

Peking University First Hospital

Beijing, Beijing Municipality, 100024, China

Location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Department of Cardiology, Union Hospital, Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

QUANZHOU First Hospital

Quanzhou, Fujian, 362002, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Southeast University Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

SHANGHAI CHEST Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

ZHONGSHAN hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Renji Hospital Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

East hospital of Tongji university

Shanghai, Shanghai Municipality, China

Location

Xinhua Hospital Affiliated of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lianglong Chen, PhD, MD

  Union Hospital, Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, MD, FACC

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 28, 2012
• Study Start: March 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

CN (12)