Drug-coated Balloons in Big de Novo Coronary Disease

NCT05550233 | Unknown

• 1 other identifier: BJH-DCB-LVD
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

drug-coated balloon; de novo coronary disease

Outcome Measures

Primary Outcomes (1)

• late lumen loss，LLL

  late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI

  12 months after PCI

Secondary Outcomes (1)

• target lesion failure，TLF

  12 months after PCI

Study Arms (2)

DCB treatment

EXPERIMENTAL

drug-coated balloon in PCI

Device: drug-coated balloon

DES treatment

OTHER

drug-eluted stent in PCI

Device: drug-coated balloon

Interventions

drug-coated balloon DEVICE

drug-coated balloon in big de novo coronary disease

Also known as: drug-eluted stent

DCB treatment; DES treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Fusui Ji, MD

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Xinyue Wang, MD

CONTACT

08613651366634; pekingcner@hotmail.com

Xue Yu, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of cardiology department

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)