Coronary Artery Disease
Conditions
Keywords
Healing-Targeted Supreme, one month DAPT
Brief summary
PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.
Detailed description
This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
Interventions
DEVICEHT Supreme
HT Supreme ( R&D by Sinomed, Tianjin, China)
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Sino Medical Sciences Technology Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patient ≥18 years of age; 2. Patient has chronic stable angina, acute coronary syndromes or silent ischemia; 3. Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation; 4. The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length); 5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.
Exclusion criteria
1. under 18 years of age; 2. Unable to sign written informed consent 3. Patient is a woman who is pregnant or nursing 4. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors; 5. Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure; 6. Concurrent medical condition with a life expectancy of less than 3 years; 7. Currently participating in another trial and not yet at its primary endpoint 8. Active pathological bleeding; 9. History of intracranial haemorrhage. OCT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure. | 12 months post-procedure | PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device-oriented composite endpoint (DoCE) at all timepoints; | 30days, 6months, annually up to 3 years post procedure | VoCE is a composite clinical endpoint of: Cardiovascular Death；Target-vessel related MI；Clinically and physiologically-oriented Target lesion revascularization |
| Rate of Stent thrombosis | 30days, 6months, annually up to 3 years post procedure | Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis |
| Rate of Target-vessel failure composite endpoint | 30days, 6months, annually up to 3 years post procedure | TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization |
| Rate of Individual components of Target-vessel failure composite endpoint | 30days, 6months, annually up to 3 years post procedure | TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization |
| Rate of Bleeding according to BARC (2, 3 and 5) classification | 30days, 6months, annually up to 3 years post procedure | Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk |
| Rate of Net adverse clinical and cerebral events | 30days, 6months, annually up to 3 years post procedure | NACCE is a composite clinical endpoint of: any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria) |
| Cost-Effectiveness | hospitalization, 1 year post procedure | Cost of procedure will be collected in the eCRF(e.g. diagnostic tests, procedural materials, time of the procedure, re-angiography, repeat revascularization, etc. will be quantified). |
| Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years; | 2 and 3 years post-procedure | PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2) |
| Rate of Individual components of patient-oriented composite endpoint; | 1, 2 and 3 years post-procedure | PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2) |
| Rate of Vessel-oriented composite endpoints (VoCE) | 1, 2 and 3 years post-procedure | VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2) |
| Rate of Individual components of vessel-oriented composite endpoint; | 1, 2 and 3 years post-procedure | VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2) |
| Rate of Individual components of device-oriented composite endpoint; | 30days, 6months, annually up to 3 years post procedure | VoCE is a composite clinical endpoint of: Cardiovascular Death；Target-vessel related MI；Clinically and physiologically-oriented Target lesion revascularization |
| Rate of Pre-procedural myocardioal infarction according to 4th universal definition; | 30days, 6months, annually up to 3 years post procedure | Fourth Universal Definition of Myocardial Infarction (2018) |
| Device Success Rate | intra-operative | according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean/Minimal Stent diameter/area/volume | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Stent diameter(mm)/area(mm2)/volume(mm3) |
| Mean/maximal thickness of the struts coverage(%) | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/maximal thickness of the struts coverage |
| Mean/Minimal Lumen diameter/area/volume | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Lumen diameter(mm)/area(mm2)/volume(mm3) |
| Incomplete strut apposition（%） | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate incomplete strut apposition |
| The percentage of the struts' neointimal coverage (%) measured by OCT | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate percentage of the struts' neointimal coverage |
| Neointimal hyperplasia area/volume measured by OCT | 1 month post procedure | 80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Neointimal hyperplasia area(mm2)/volume(mm3) |
Outcome results
None listed