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| Name | Class |
|---|---|
| Sino Medical Sciences Technology Inc. | INDUSTRY |
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High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome.
The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients.
Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)). | Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo) | At 335 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk. | the rate of occurrence of the primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) in patients with HBRand high ischemic risk | At 335 days and one year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Grenoble | Isère | 38700 | France |
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| Evaluate the one-year frequency of death from any cause | All-cause death rate | At 335 days and one year |
| Evaluate the one-year frequency of cardiovascular deaths | Cardiovascular death rate | At 335 days and one year |
| Evaluate the one-year incidence of myocardial infarction | Myocardial infarction rate | At 335 days and one year |
| Evaluate the one-year incidence of ischemic stroke | Ischemic stroke rate | At 335 days and one year |
| Evaluate the one-year frequency of ischemia-driven revascularizations | ischemia-driven revascularizations rate | One year |
| Evaluate the one-year incidence of defined stent thrombosis | defined stent thrombosis rate | One year |
| Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC) | minor and major bleeding according to Bleeding Academic Research Consortium (BARC) rate | One year |
| Evaluate the frequency of other cardiovascular adverse events | other cardiovascular adverse events rate | at 335 days and One year |
| Evaluate the rate of serious adverse events related to the device and/or investigation procedure. | Rate of serious adverse events related to the device and/or investigation procedure | At 335 and One year |