Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels

A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter for the Treatment of De Novo Coronary Artery Small Vessel Lesions.

To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Sirolimus-coated Coronary Balloon Dilatation Catheter; Device: Drug-coated Coronary Balloon Dilatation Catheter

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old, gender is not limited
2. Diagnosed with stable or unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia
3. Suitable for balloon angioplasty
4. Be able to understand the purpose of the trial, be willing to cooperate in the follow-up, and voluntarily sign an informed consent form.
5. Primary coronary small vessel lesions with a visual lesion length of ≤36mm and a visual lesion diameter of ≥2.00mm and ≤2.75mm
6. Target lesions with ≥70% or ≥50% diameter stenosis with evidence of ischemia before interventional therapy
7. Residual stenosis of ≤30% visualized after pre-interventional dilatation of the target lesion without type C or higher entrapment
8. In the presence of multiple lesions requiring treatment, one of the lesions that meets the requirements should be selected as the target lesion, and the non-target lesion should be in a different vascular branch from the target lesion.
9. Patients with at most two non-target lesions requiring simultaneous treatment, and the non-target lesion should undergo interventional therapy before the target lesion, and there are no serious complications after treatment.

Exclusion Criteria:

Patients who had a myocardial infarction within 7 days before enrollment (2) Patients with cardiogenic shock (3) Patients with renal insufficiency (eGFR < 30 ml/min) or vital organ failure (4) Patients with known allergy or intolerance to contrast media or to rapamycin, paclitaxel and/or their analogs (5) Patients with hematologic disorders, or contraindications to anticoagulant/antiplatelet agents, or intolerance to aspirin or clopidogrel (6) Patients with severe valvular heart disease or who have undergone heart transplantation (7) Patients who are not suitable for coronary artery bypass graft surgery (CABG) (8) Patients with congestive heart failure or NYHA class IV (9) Patients who have had a stroke within 6 months prior to enrollment, or have a history of gastrointestinal bleeding or active gastric ulcers, or who have been determined by the investigator to have a bleeding constitution (10) Patients with a life expectancy of less than 1 year (11) Pregnant or lactating females (12) Patients who are participating in clinical trials of other drugs or medical devices (13) Patients who, in the opinion of the investigator, are not suitable for enrollment for other reasons.

(14) Totally occluded (TIMI grade 0) lesions (15) Presence of coronary artery spasm without significant stenosis (16) Unprotected left main stem lesions (17) Patients with a bifurcation lesion (branch diameter ≥2.00 mm) as the target lesion (18) Patients with target lesions that are severely tortuous (preventing smooth catheter passage) or severely calcified (19) Patients with secondary stenosis caused by pre-dilatation of the target lesion (20) Patients with a well-defined thrombus in the target vessel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Sirolimus-coated Coronary Balloon Dilatation Catheter	Device: Sirolimus-coated Coronary Balloon Dilatation Catheter; During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
Active Comparator: Control Group; Drug Eluting Balloon Catheter	Device: Drug-coated Coronary Balloon Dilatation Catheter; During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late luminal loss (LLL)	Late luminal loss (LLL) within the target lesion segment at 9 months postoperatively	9 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Successful delivery and dilatation of the drug-coating balloon catheter across lesion, and target lesion residual stenosis≤30% (visual inspection) without additional interventional treatment.	Immediately after PTCA

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: BM-D19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No