Clinical trial NCT04918615: Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: drug coated balloon catheter
coronary bifurcation lesion
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Percent Diameter Stenosis (DS) of side branch
timeFrame: 9 months
Secondary outcomes:
measure: Late lumen loss (LLL) of side branch
timeFrame: 9 months
Other outcomes:
measure: Immediate Success Endpoint
timeFrame: 7 days
measure: DoCE
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: PoCE
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Death
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Myocardial infarction
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Target lesion Revascularization
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Target vessel Revascularization
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Any coronary revascularization
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: Thrombotic events
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: AE & SAEs rate
timeFrame: 30 days, 6 months, 9 months, 12 months, 24 months post-procedure
measure: side branch re-stenosis rate
timeFrame: 9 months
measure: main branch re-stenosis rate
timeFrame: 9 months
measure: In-segment late loss of the main branch (mm)
timeFrame: 9 months
measure: In-segment Stenosis degree of the main branch (%)
timeFrame: 9 months
Locations:
city: Shengyang
country: China
facility: General Hospital of the PLA Northern Theater Command
state: Liaoning
Study officials:
References: