Sirolimus DEB in Coronary Bifurcation Lesions

NCT04896177 | Recruiting

• 1 other identifier: SalubrisDEB001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

Conditions

Coronary Bifurcation Lesions

Keywords

drug-eluting balloon; coronary bifurcation lesions; coronary heart disease; sirolimus

Outcome Measures

Primary Outcomes (1)

• Stenosis of lumen diameter of target lesion branch

  The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%

  9 months (±30 days)

Secondary Outcomes (6)

• Success rate of interventional treatment

  Index Procedure

• Incidence of restenosis of target lesions

  9 months (±30 days)

• Late lumen loss (LLL)

  9 months (±30 days)

• Target lesions revascularization (TLR)

  1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)

• Target vessel revascularization (TVR)

  1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)

Study Arms (2)

Sirolimus drug-eluting coronary balloon catheter

EXPERIMENTAL

Manufacturer: Shenzhen Salubris Pharmaceuticals Co., Ltd. This product is a sirolimus drug eluting balloon catheter for coronary artery therapy. It is a rapidly exchangeable PTCA balloon catheter (RX), effective length is 140cm, and compatible with 0.014 in. (0.36mm) guide wire. The balloon at the distal end of the catheter was coated with sirolimus, an anti-proliferative and anti-inflammatory drug.

Device: Sirolimus drug-eluting coronary balloon catheter

Drug-eluting balloon catheter

ACTIVE COMPARATOR

Manufacturer: Liaoning Yinyi Biotechnology Co., Ltd Coated with paclitaxel.

Device: Paclitaxel drug-eluting coronary balloon catheter

Interventions

Sirolimus drug-eluting coronary balloon catheter DEVICE

Patients in experimental group will undergo PCI, using sirolimus drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.

Sirolimus drug-eluting coronary balloon catheter

Paclitaxel drug-eluting coronary balloon catheter DEVICE

Patients in control group will undergo PCI, using paclitaxel drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.

Drug-eluting balloon catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female that ages 18-85 year old;
• Having evidence of myocardial ischemia;
• Voluntarily participates in this study and signs the informed consent form (ICF);
• Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;
• Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
• Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;
• Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
• The target vessel diameter was 2.0mm-4.0mm.

You may not qualify if:

• Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
• Cardiogenic shock patients;
• With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;
• ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
• With severe congestive heart failure or NYHA class Ⅳ heart failure;
• With severe valvuar heart disease;
• Heart transplant patients;
• With renal insufficiency (creatinine \> 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
• With a life expectancy less than 1 year;
• With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;
• With known allergies to paclitaxel, sirolimus, contrast agents, etc.;
• Participating in clinical trials of other drugs or devices and has not met the primary endpoint;
• Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;
• Intra-stent restenosis;
• High-risk left main disease;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Wei Huang, Dr.

CONTACT

+86 83867888; huangwei01@salubris.com

Jiatian Cao, Dr.

CONTACT

+86 83867888; amcjt@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 21, 2021
• Study Start: March 18, 2021
• Primary Completion: September 18, 2025
• Study Completion (Estimated): September 18, 2026
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

CN (1)