Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions

Coronary Artery Disease Clinical Trial

— PROMISE-BIF  

Official title:

PROMISE-BIF ：A Prospective, Multicenter, Randomized Controlled Trial to Compare the Efficacy and Safety of Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcated Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04918615
• Other study ID #: D-IC-040
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.

Description:

PROMISE-BIF is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll about 234 participants. All participants will undergo PCI with sirolimus drug coated balloon catheter or paclitaxel drug coated balloon catheter and be followed-up to 24 months.

The Target Lesion defined as the true bifurcation, include the main branch and side branch lesion.

The bifurcation lesions were classified by Medina (1.1.1, 1.0.1, and 0.1.1). The image data will be analyzed and evaluated independently by a third-party imaging laboratory.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female ages 18-80 years old

• Participants with myocardial ischemia, stable or unstable angina pectoris, old myocardial infarction, or Stabled myocardial infarction (occurred more than 7 days before enrollment, including non-ST elevation and ST elevation myocardial infarction)

• Participants are are eligible to undergo any type of coronary revascularization surgery, such as balloon angioplasty, stenting, and coronary artery bypass grafting (CABG);

• Participants Can understand the trial's purpose, voluntarily participate and acknowledge all the risks and benefits, providing written informed consent and are willing to accept invasive radiographic during the follow-up period.

• Angiography confirmed as De novo bifurcation lesion, the stenosis rate of side branch (diameter) =70%

• Suitable for PCI and the side branch lesions is not expected to stent implantation, and no DCB treatment 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

• Up to 2 vessels that need to be treated, total intended treat lesions' amount will not exceed 3

• At most one primary bifurcation lesion that needs treatment (including Medina classification 1.1.1, 1.0.1, 0.1.1), ostium stenosis degree (diameter) =70% (visual);

• Patients are suitable for PCI and side branch is not expected to implant a stent, the main branch will not apply drug coated balloon; the main branch will implant a stent, usually the main branch and side branch will have Kissing Balloon Inflation

• The side branch is pre-dilated successfully, no C or upper grade dissection, no tear or other complications occurred, residual stenosis =50%, TIMI3

• The reference diameter of the target lesion side branch is 2.0~4.0 mm, the length of the lesion in side branch is =38 mm, and the length of the lesion in main branch is =70 mm

Exclusion Criteria:

• Any AMI occurred within 1 week before operation

• Unstable arrhythmias, such as high-risk ventricular premature beats, ventricular tachycardia

• severe heart failure (above NYHA IV) or Left ventricular ejection fraction (LVEF) <30% (ultrasound or left ventricular angiography)

• Renal function insufficiency: Serum creatinine >177µmol/L; Or undergoing hemodialysis;

• definite hemorrhagic tendency, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;

• PCI planned within 1 year

• Have a history of peptic ulcer or gastrointestinal hemorrhage in the past 6 months; Have a history of cerebrovascular accidents (stroke) such as cerebral hemorrhage, cerebral infarction in the past 6 months;

• allergic to contrast agent, paclitaxel, and rapamycin and its derivatives

• Has been diagnosed as advanced cancer and other serious diseases, lifespan are expected less than 12 months or hard to complete the 12-month follow up;

• Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements; Or other reasons that considered by the investigator, it be unsuitable to enroll the participant;

• Be participating in any other clinical trials, or have participated in clinical trials of other drugs or medical devices before being selected but have not reached the timeline of the primary endpoint;

• Female who are pregnant or breastfeeding (women who may become pregnant must undergo a pregnancy test within 7 days before the baseline surgery);Or have fertility plan/can not have adequate contraception during the study period

• Three vessel disease and all the vessels need revasculization

• Left main and its bifurcation lesions;

• thrombus in the bifurcation lesion, or tortuose lesion that the balloon catheter will not pass through;

• Side branch lesion segment of target lesion is a total occlusion lesion

• side branch is severely calcified, and cannot be pre-dilated or dilated while do kissing balloon inflation;

• Target lesion (including main branch and branch) is in-stent re-stenosis

• Dissection above grade C or residual stenosis >50% after pre-dilation of the target lesion branch vessel disease or double kissing balloon dilation;

• Two or more non-target lesions that need to be treated, the non-target lesion cannot be processed before the target lesion or the treatment fails;

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• PCI
Patients in experimental group will undergo PCI with drug coated balloon catheter to treat the side branch of the coronary bifurcation lesion.

Locations

Country	Name	City	State
China	General Hospital of the PLA Northern Theater Command	Shengyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immediate Success Endpoint	Immediate Success Endpoint including Technical success, Lesion success and Procedural success.; Technical success defined as the success of the study device in reaching the target lesion branch vascular lesions, dilatating and retracting successfully with residual stenosis of the branch vessel lesion =30%(visual inspection); Lesion success defined as the main and branch vessels of the target lesion residual stenosis Residual stenosis = =30%, furthermore blood flow is TIMI 3 (visual inspection) after treatment with any interventional method Procedural success defined as the absence of device-related composite end point events during the hospitalization period (up to 7 days after surgery) on the basis of Lesion success.	7 days
Other	DoCE	Defined as a composite of cardiac death, target vessel-related MI, or ischemia-driven side branch lesion revascularization events at 30 days, 6 months, 9 months and 12 months	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	PoCE	Defined as a composite rate of all cause death, all MI or any revasculariztion at 30 days, 6 months, 9 months, and 12 months	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Death	Cardiac, Vascular, Non-cardiovascular related	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Myocardial infarction	Target vessel related, Non-target vessel related	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Target lesion Revascularization	Lesion revascularization in main branch, side branch or both, ischemic driven or non-ischemic driven	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Target vessel Revascularization	Ischemia-driven , Not ischemia-driven	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Any coronary revascularization	Ischemia-driven , Not ischemia-driven	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	Thrombotic events	ARC defined: acute, subacute, late	30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	AE & SAEs rate		30 days, 6 months, 9 months, 12 months, 24 months post-procedure
Other	side branch re-stenosis rate	the proportion of patients with re-stenosis in the side branch, stenosis degree >50%	9 months
Other	main branch re-stenosis rate	the proportion of patients with re-stenosis in the main branch, stenosis degree >50%	9 months
Other	In-segment late loss of the main branch (mm)	The minimum lumen diameter (MLD) immediately after stent implantation was subtracted from the MLD at follow-up	9 months
Other	In-segment Stenosis degree of the main branch (%)		9 months
Primary	Percent Diameter Stenosis (DS) of side branch	Stenosis of lumen diameter of lesion segment of the side branch	9 months
Secondary	Late lumen loss (LLL) of side branch	late lumen loss of lesion segment of the side branch	9 months