Sirolimus DEB in Coronary Bifurcation Lesions

Coronary Bifurcation Lesions Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896177
• Other study ID #: SalubrisDEB001
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: September 18, 2026

Study information

• Verified date: May 2021
• Source: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Contact: Wei Huang, Dr.
• Phone: +86 83867888
• Email: huangwei01[@]salubris.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 with would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: September 18, 2026
• Est. primary completion date: September 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Male or Female that ages 18-85 year old;

2. Having evidence of myocardial ischemia;

3. Voluntarily participates in this study and signs the informed consent form (ICF);

4. 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;

5. Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) =70%;

6. 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;

7. Residual stenosis of the side-branch lesion ?50% after pre-treatment, with a TIMI flow grade 3;

8. The target vessel diameter was 2.0mm-4.0mm.

Exclusion Criteria:

1. Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;

2. Cardiogenic shock patients;

3. 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;

4. ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;

5. With severe congestive heart failure or NYHA class ? heart failure;

6. With severe valvuar heart disease;

7. Heart transplant patients;

8. With renal insufficiency (creatinine > 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;

9. With a life expectancy less than 1 year;

10. With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;

11. With known allergies to paclitaxel, sirolimus, contrast agents, etc.;

12. Participating in clinical trials of other drugs or devices and has not met the primary endpoint;

13. Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;

14. Intra-stent restenosis;

15. High-risk left main disease;

16. Other patients considered by the investigator to be unsuitable for inclusion.

Related Conditions & MeSH terms

• Coronary Bifurcation Lesions

Intervention

Device:
• Sirolimus drug-eluting coronary balloon catheter
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.
• Paclitaxel drug-eluting coronary balloon catheter
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.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Salubris Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Success rate of interventional treatment	Including device success, pathological success and clinical success	Index Procedure
Secondary	Incidence of restenosis of target lesions	Restenosis defined as angiographic stenosis =50%	9 months (±30 days)
Secondary	Late lumen loss (LLL)		9 months (±30 days)
Secondary	Target lesions revascularization (TLR)	Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Secondary	Target vessel revascularization (TVR)	Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Secondary	Target lesion failure rate (TLF)	Including cardiac death, target vascular-associated myocardial infarction, and target lesion revascularization	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)