Sirolimus DEB in Coronary Bifurcation Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sirolimus drug-eluting coronary balloon catheter, Paclitaxel drug-eluting coronary balloon catheter.
- Who it may be relevant to
- Registry conditions: Coronary Bifurcation Lesions. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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. - Device 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.
Primary outcome measures
- Stenosis of lumen diameter of target lesion branch [Time frame: 9 months (±30 days)]
Secondary outcome measures (6)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT04896177 · SalubrisDEB001