Health TrialsbyHealthPanel

Sirolimus DEB in Coronary Bifurcation Lesions

ConditionCoronary Bifurcation Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sirolimus drug-eluting coronary balloon catheter

    Device

    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 catheter

    Device

    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.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Sirolimus drug-eluting coronary balloon catheterExperimental treatment 1 intervention
Group B: Drug-eluting balloon catheterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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%

Time frame
9 months (±30 days)

Secondary outcomes

1

Success rate of interventional treatment

Including device success, pathological success and clinical success

Time frame
Index Procedure
2

Incidence of restenosis of target lesions

Restenosis defined as angiographic stenosis ≥50%

Time frame
9 months (±30 days)
3

Late lumen loss (LLL)

Time frame
9 months (±30 days)
4

Target lesions revascularization (TLR)

Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)

Time frame
1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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