Coronary Artery DiseasePROMISE-BIFNCT04918615
Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions
A study testing PCI in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of the PLA Northern Theater Command
Shengyang, Liaoning
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- PCI
- Keywords
- drug coated balloon catheter, coronary bifurcation lesion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Patients in experimental group will undergo PCI with drug coated balloon catheter to treat the side branch of the coronary bifurcation lesion.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus coated balloon catheter | Experimental | Manufacturer: Shanghai MicroPort Medical Group Co, Ltd. Receives: Procedure: PCI |
| Paclitaxel coated balloon catheter | Active comparator | Manufacturer: Liaoning Yinyi Biotechnology Co., Ltd Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Diameter Stenosis (DS) of side branch
Stenosis of lumen diameter of lesion segment of the side branch
Measured: 9 months
Secondary outcomes (1)
Late lumen loss (LLL) of side branch
late lumen loss of lesion segment of the side branch
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start28 Feb 2021
- Primary completion31 Oct 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918615
- Sponsor's protocol ID
- D-IC-040
- Acronym
- PROMISE-BIF
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04918615
- Acronym / sponsor ID
- PROMISE-BIF / D-IC-040
- Conditions
- Coronary Artery Disease
- Keywords
- drug coated balloon catheter, coronary bifurcation lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus coated balloon catheter | Experimental | Procedure: PCIManufacturer: Shanghai MicroPort Medical Group Co, Ltd. |
| Paclitaxel coated balloon catheter | Active comparator | Procedure: PCIManufacturer: Liaoning Yinyi Biotechnology Co., Ltd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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％
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIPatients in experimental group will undergo PCI with drug coated balloon catheter to treat the side branch of the coronary bifurcation lesion. | Procedure or surgery | Paclitaxel coated balloon catheter, Sirolimus coated balloon catheter |
Primary outcome
Percent Diameter Stenosis (DS) of side branch
Time frame: 9 months
Stenosis of lumen diameter of lesion segment of the side branch
1 secondary outcome
Late lumen loss (LLL) of side branch
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Diameter Stenosis (DS) of side branch (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.