Health Condition 1: null- Patients who are eligible for an Angioplasty
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
TRANSLUMINA THERAPEUTICS LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient >= 18 years old. 2. Patient was treated for percutaneous coronary(PCI). 3. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone. 4. Candidate was operated for coronary artery bypass graft (CABG) . 5. Stable angina pectoris (Canadian Cardiovascular Society â?? CCS-Class 1, 2, 3 or 4)or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ECG-TT, SPECT, Stress echocardiography or Cardiac CT). 6. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study). Angiographic Inclusion Criteria 1. Patient was treated for elective stenting of 1 or 2 stenotic lesions in a native coronary artery. 2. Reference vessel >= 2.0 mm and 3. Target lesion 4. Protected left main lesion with >50% stenosis. 5. Target lesion stenosis >= 70% and 6. Target lesion stenosis
Exclusion criteria
Exclusion criteria: 1. Patients enrolled in any other drug or investigational device or in another stent trial prior 2 years, planned elective surgery or percutaneous intervention within the subsequent 3 months, staged procedure within 9 months post procedure. 2. Patient requiring treatment with a device other than PTCA prior to stent placement. 3. Target lesion exhibiting an intraluminal thrombus at any time. Lesion location that is within 5 mm of the origin of the left anterior descending or circumflex or target lesion is in a bypass graft. 4. Any co-morbid conditions impacting the scientific integrity of the trial, such as patients ability to participate in the trial or to comply with the follow-up requirements, life expectancy of less than 12 months. 5. Documented left ventricular ejection fraction (LVEF) 6. Patients with diagnosis of MI within 48 hours or suspected acute MI at time of enrollment. 7. History of cerebrovascular accident or transient ischemic attack in the last 6 months. 8. Leukopenia, Neutropenia ,Thrombocytopenia, active peptic ulcer or active GI bleeding. 9. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions. 10. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, stainless steel or sensitivity to contrast media, which cannot be adequately pre-medicated. 11. Serum creatinine level >2.0 mg/dl within 7 days prior to index procedure. 12. Patients unable to tolerate dual anti-platelets therapy (DAPT) for 360 days post procedure. 13. Unprotected left main coronary artery disease. 14. Target vessel with any lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) Cardiac death MI ( Q wave and non-Q wave) Emergent bypass surgery Clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 360 days. Timepoint: 30, 180, 360 days | — |
Secondary
| Measure | Time frame |
|---|---|
| All death Cardiac death MI Clinically driven TLR Stent Thrombosis (definite/probable, ARC defined) Acute success rates : device success, Lesion success and Procedure success. Timepoint: 30, 180 and 360 days | — |
Countries
India
Contacts
Public ContactRhea Sharma
translumina therapeutics lop
Outcome results
None listed