Coronary Artery In-stent Restenosis
Conditions
Brief summary
This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.
Detailed description
This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.
Interventions
DEVICEcoronary artery in-stent restenosis
treat the petients with coronary artery in-stent restenosis
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 1.18-75 years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. * Angiographic Inclusion Criteria: 1. One or two target lesions; 2. Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm; 3. The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia; 4. There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be \>10mm.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment Late Lumen Loss | 9 months after coronary angiography | In-segment Late Lumen Loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Immediately after the index procedure | Defined as target lesions with residual stenosis ≤30% and TIMI3 blood flow after any interventional treatment, without thrombus or dissection need interention. |
| Clinical success | At time of procedure up to 7 days in hospital | Defined as the absence of device-related composite endpoint events during hospitalization (up to 7 days after surgery) on the basis of procedural success. |
| Device-oriented composite endpoints (Target Lesion Failure) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | TLF is defined as the composited endpoints of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization. |
| Patient-oriented composite endpoint (PoCE) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Patient-oriented composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization. |
| Death (Cardiac, Non-cardiac) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Defined as death due to the following causes. Acute myocardial infarction; cardiac perforation/cardiac tamponade; arrhythmia or abnormal conduction; death due to surgical complications, including bleeding, vascular repair, transfusion response, or coronary artery bypass surgery; anything that does not rule out death from cardiac causes. Non-cardiac death: defined as death from causes other than the above cardiac causes. |
| Device success | during the procedure | defined as residual stenosis ≤30% and TIMI3 blood flow after drug-eluting balloon dilation. |
| The number and rate of Target Lesion Revascularization (TLR) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR) |
| The number and rate of Target Vessel Revascularization (TVR) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR) |
| The number and rate of Any Revascularization | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Ischemia-driven , Not ischemia-driven |
| The number and rate of Thrombosis (per ARC definition) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable) |
| In-segment angiography binary restenosis (ABR, %) | 9 months after index procedure | Defined as the proportion of subjects with restenosis occurring in the target lesion segment and the diameter stenosis ≥50%.Quantitative coronary angiography analysis (QCA) calculation (1- 9 months after the operation of the original stent restenosis in-segment residual minimum lumen diameter / reference vessel diameter) ×100% |
| The number and rate of Myocardial Infarction (MI) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI) |
Contacts
Primary ContactLing Tao
Backup ContactLing Tao
Outcome results
None listed