Health Condition 1: I79- Disorders of arteries, arteriolesand capillaries in diseases classified elsewhere Health Condition 2: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention1: Paclitaxel coated balloons (Protege/Protege NC): The patients will be randomised in the study in 1:1:1 ratio in (Protege/Protege NC), Paclitaxel coated Balloon (Agent) and Contemporary
Sponsors
Translumina Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 2. Patient with NSTE-ACS or CCS with either symptoms or ischemia on non-invasive or invasive testing (i.e. FFR or iFR, CMR, SPECT, PET-CT or stress-echo). 3. The patient must be able to understand and provide written informed consent and comply with all study procedures. 4. Life expectancy of more than 2 years. Angiographics inclusion: 1. One or more trial target vessel (LAD, CX or RCA, or of their branches). 2. The target vessel or target lesion matches at least one of the following criteria. 3. Lesion preparation must be according to the 3rd DCB consensus.
Exclusion criteria
Exclusion criteria: 1. STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI. 2. Pregnancy or nursing declarations (As per country specific guideline). 3. LVEF less than 30. 5. Allergy to imaging contrast media which cannot be adequately pre-medicated. 6. Stroke or TIA during the last 6 months, or any prior intracranial hemorrhage. 7. Active peptic ulcer or upper gastrointestinal bleeding within last 6 months. 8. Known renal insufficiency with an eGFR less than 30 ml per min., or subject on dialysis, or acute renal failure (as per physician judgment) 9. Planned surgery within 6 months with the necessity to stop DAPT. Angiographic exclusion criteria: 1. Target lesion is in the left main coronary artery. 2. Target lesion is in a coronary artery bypass graft. 3. Flow limiting target vessel thrombus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device oriented composite endpoint (DOCE) of: Cardiac death, New target vessel - related myocardial infarction (TV-MI), Ischemia-driven target-lesion revascularization (TLR)Timepoint: At 1 months, 6 months, 12 months , 18 months and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient oriented composite endpoint (POCE) of: All-cause death, Any Stroke, All new MI (TV and non-TV related), Unplanned ischemia-driven repeat revascularization All individual components of DOCE and POCE Definite or probable vessel (stent) thrombosis, Ischemia-driven target-vessel revascularization (TVR), Major bleeding (BARC type 3 to 5)Timepoint: within 2 years. | — |
Countries
Austria, France, Germany, India, Ireland, Italy, Netherlands, Spain, Switzerland
Contacts
Public ContactDr Brijesh Kumar Mishra
Medanta The Medicity
Outcome results
None listed