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Withdrawn of the research project based on the company's decision
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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HT Supreme | Experimental | Device: HT Supreme ( R&D by Sinomed, Tianjin, China) Drug: 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HT Supreme | Device | HT Supreme ( R&D by Sinomed, Tianjin, China) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patient-oriented Composite Endpoint (PoCE) at 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) | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years; | 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) | 2 and 3 years post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of the struts' neointimal coverage (%) measured by OCT | 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 | 1 month post procedure |
| Neointimal hyperplasia area/volume measured by OCT |
Inclusion Criteria:
Exclusion Criteria:
OCT exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, PH.D | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Haibo Jia, PH.D | The Second Affiliated Hospital of Harbin Medical University | Study Director |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Rate of Individual components of patient-oriented composite endpoint; | 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) | 1, 2 and 3 years post-procedure |
| Rate of Vessel-oriented composite endpoints (VoCE) | VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2) | 1, 2 and 3 years post-procedure |
| Rate of Individual components of vessel-oriented composite endpoint; | VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2) | 1, 2 and 3 years post-procedure |
| Rate of Device-oriented composite endpoint (DoCE) at all timepoints; | VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization | 30days, 6months, annually up to 3 years post procedure |
| Rate of Individual components of device-oriented composite endpoint; | VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization | 30days, 6months, annually up to 3 years post procedure |
| Rate of Pre-procedural myocardioal infarction according to 4th universal definition; | Fourth Universal Definition of Myocardial Infarction (2018) | 30days, 6months, annually up to 3 years post procedure |
| Device Success Rate | according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)) | intra-operative |
| Rate of Stent thrombosis | Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis | 30days, 6months, annually up to 3 years post procedure |
| Rate of Target-vessel failure composite endpoint | TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization | 30days, 6months, annually up to 3 years post procedure |
| Rate of Individual components of Target-vessel failure composite endpoint | TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization | 30days, 6months, annually up to 3 years post procedure |
| Rate of Bleeding according to BARC (2, 3 and 5) classification | Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk | 30days, 6months, annually up to 3 years post procedure |
| Rate of Net adverse clinical and cerebral events | 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) | 30days, 6months, annually up to 3 years post procedure |
| Cost-Effectiveness | 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). | hospitalization, 1 year 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) |
| 1 month post procedure |
| Mean/Minimal Stent diameter/area/volume | 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) | 1 month post procedure |
| Mean/maximal thickness of the struts coverage(%) | 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 | 1 month post procedure |
| Mean/Minimal Lumen diameter/area/volume | 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) | 1 month post procedure |
| Incomplete strut apposition(%) | 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 | 1 month post procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |