Drug-coated Balloons in Big de Novo Coronary Disease

NCT ID: NCT05550233

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-31

Brief Summary

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCB treatment

drug-coated balloon in PCI

Group Type: EXPERIMENTAL

drug-coated balloon

Intervention Type: DEVICE

drug-coated balloon in big de novo coronary disease

DES treatment

drug-eluted stent in PCI

Group Type: OTHER

drug-coated balloon

Intervention Type: DEVICE

drug-coated balloon in big de novo coronary disease

Interventions

drug-coated balloon

drug-coated balloon in big de novo coronary disease

Intervention Type: DEVICE

Other Intervention Names

drug-eluted stent

Eligibility Criteria

Inclusion Criteria

• Over 18 years old;
• Asymptomatic myocardial ischemia, stable or unstable angina;
• The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
• Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
• The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.

Exclusion Criteria

• Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
• Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
• Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
• Life expectancy is less than 12 months;
• eGFR≤30ml/min/1.73m2 or blood purification treatment;
• LVEF≤40% or NYHA cardiac function class≥III;
• Clinical conditions of severe hepatic insufficiency and coagulation disorder
• Pregnant or breastfeeding women;
• Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
• Reference lumen diameter > 4.0mm;
• Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
• The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
• Chronic total occlusive disease;
• Left main stem disease;
• Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
• Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xue Yu

Vice director of cardiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fusui Ji, MD

Role: STUDY_CHAIR

Beijing Hospital

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinyue Wang, MD

Role: CONTACT

pekingcner@hotmail.com

08613651366634

Xue Yu, MD

Role: CONTACT

Facility Contacts

Xinyue Wang, MD

Role: primary

pekingcner@hotmail.com

08613651366634

Other Identifiers

BJH-DCB-LVD

Identifier Type: -

Identifier Source: org_study_id