Clinical trial NCT05550233: Drug-coated Balloons in Big de Novo Coronary Disease
Official title: A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: drug-coated balloon
de novo coronary disease
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: late lumen loss，LLL
timeFrame: 12 months after PCI
Secondary outcomes:
measure: target lesion failure，TLF
timeFrame: 12 months after PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Fusui Ji, MD
role: STUDY_CHAIR
References: