Coronary Bifurcation LesionsNCT04896177
Sirolimus DEB in Coronary Bifurcation Lesions
A study testing Sirolimus drug-eluting coronary balloon catheter and Paclitaxel drug-eluting coronary balloon catheter in people with Coronary Bifurcation Lesions, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Bifurcation Lesions
- What is being tested?
- Sirolimus drug-eluting coronary balloon catheter and Paclitaxel drug-eluting coronary balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2021to 18 Sep 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Other patients considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Jiatian Cao, Dr., +86 83867888 ext. 88946, amcjt@126.com
About this study
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
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.
Read the detailed 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.
- Conditions
- Coronary Bifurcation Lesions
- Being tested
- Sirolimus drug-eluting coronary balloon catheter, Paclitaxel drug-eluting coronary balloon catheter
- Keywords
- drug-eluting balloon, coronary bifurcation lesions, coronary heart disease, sirolimus
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus drug-eluting coronary balloon catheterDevice
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 catheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sirolimus drug-eluting coronary balloon catheter |
| Drug-eluting balloon catheter | Active comparator | Manufacturer: Liaoning Yinyi Biotechnology Co., Ltd Coated with paclitaxel. Receives: Device: Paclitaxel drug-eluting coronary balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 9 months (±30 days)
Secondary outcomes (6)
Success rate of interventional treatment
Including device success, pathological success and clinical success
Measured: Index Procedure
Incidence of restenosis of target lesions
Restenosis defined as angiographic stenosis ≥50%
Measured: 9 months (±30 days)
Late lumen loss (LLL)
Measured: 9 months (±30 days)
Target lesions revascularization (TLR)
Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Measured: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target vessel revascularization (TVR)
Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Measured: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target lesion failure rate (TLF)
Including cardiac death, target vascular-associated myocardial infarction, and target lesion revascularization
Measured: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start18 Mar 2021
- Primary completion18 Sep 2025 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896177
- Sponsor's protocol ID
- SalubrisDEB001
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04896177
- Acronym / sponsor ID
- SalubrisDEB001
- Conditions
- Coronary Bifurcation Lesions
- Keywords
- drug-eluting balloon, coronary bifurcation lesions, coronary heart disease, sirolimus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 18 Sep 2025 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 21 May 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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus drug-eluting coronary balloon catheter | Experimental | Device: Sirolimus drug-eluting coronary balloon catheterManufacturer: 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. |
| Drug-eluting balloon catheter | Active comparator | Device: Paclitaxel drug-eluting coronary balloon catheterManufacturer: Liaoning Yinyi Biotechnology Co., Ltd Coated with paclitaxel. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%;
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| Sirolimus drug-eluting coronary balloon catheterPatients 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. | Device | Sirolimus drug-eluting coronary balloon catheter |
| Paclitaxel drug-eluting coronary balloon catheterPatients 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. | Device | Drug-eluting balloon catheter |
Primary outcome
Stenosis of lumen diameter of target lesion branch
Time frame: 9 months (±30 days)
The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%
6 secondary outcomes
Success rate of interventional treatment
Time frame: Index Procedure
Incidence of restenosis of target lesions
Time frame: 9 months (±30 days)
Late lumen loss (LLL)
Time frame: 9 months (±30 days)
Target lesions revascularization (TLR)
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target vessel revascularization (TVR)
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target lesion failure rate (TLF)
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus drug-eluting coronary balloon catheter and Paclitaxel drug-eluting coronary balloon catheter in people with Coronary Bifurcation Lesions, run by Shenzhen Salubris Pharmaceuticals 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 8 inclusion and 16 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 21 May 2021. 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?
Contact Wei Huang, Dr. (+86 83867888 ext. 88946, huangwei01@salubris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stenosis of lumen diameter of target lesion branch (time frame: 9 months (±30 days)). 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 21 May 2021.