PMS Registry to evaluate safety and performance of AdvaPro® DES in patients with Coronary artery disease-Prospective.
- Conditions
- Health Condition 1: I219- Acute myocardial infarction, unspecifiedHealth Condition 2: I209- Angina pectoris, unspecified
- Registration Number
- CTRI/2023/11/059399
- Lead Sponsor
- Advanced MedTech Solutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
To be eligible for participation in this Clinical Registry, subjects must meet all of the following criteria: Real world, all comer’s ? patients will be included in registry:
Subjects must be at least > 18 years of age and < 85 years of age.
The subject or his legal representative is able to provide written informed consent before any study-related procedure is performed.
Subject must be acceptable candidate with anatomy suitable for CABG or PCI with AdvaPro® DES.
Subject agrees to the Clinical Registry related follow-up assessments.
Subject has presence of one or more coronary artery stenosis in a native coronary artery with visually estimated of 2.25 to 4.50 mm and that can be covered with available length of AdvaPro® DES.
Subject has up to 3 de novo target lesions with a maximum of 2 de novo target lesions per epicardial vessel and with a maximum of 2 target vessels.
Subject must have target lesion treatable with a single stent and must measure 36 mm or less in length by visual estimate (2 mm or more of non-diseased tissue on either side of the target lesion should be covered by the registry device).
If more than 1 target lesion is treated, the reference vessel diameter and lesion length of each target lesion must meet the above criteria.
Target lesions must be in major artery or branch with a visual estimated stenosis of 50% or greater and less than 100% with a TIMI flow grade = 1.
Previous percutaneous intervention of lesions in a target vessel (including side branches) is allowed if done 9 or more months before the study procedure and greater than 10 mm from the current target lesion.
Non-study percutaneous interventions for lesions in a nontarget vessel are allowed if done 9 or more months before the study procedure, in the absence of documented ischemia or angiographic restenosis related to the vessel.
Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia (eg, stable or unstable angina, stabilized NSTEMI confirmed by serum markers, ischemia by positive functional study, abnormal fractional flow reserve [FFR], or a reversible change in the electrocardiogram [ECG] consistent with ischemia)
To be eligible for participation in this Clinical Registry, subjects must not meet any of the following criteria:
• Subject having target lesion in unprotected left main coronary artery location.
• Subject having LVEF (Left ventricular ejection fraction) less than 30%.
• Subject has current unstable arrhythmias or intractable angina with ECG changes or shock requiring pressors or mechanical assist device (Intra-Aortic balloon pump, left ventricular assist device, Impella, etc.).
• Subject having received heart transplant or any other organ transplant or is on a waiting list for transplant.
• Subject with known hypersensitivity or contraindications to sirolimus, aspirin, clopidogrel, heparin, cobalt chromium / nickel, contrast media as per the Instructions for use of AdvaPro® DES.
• Subject currently participating in another clinical study that has not yet reached its primary endpoint.
• Subject is currently pregnant or breast-feeding or is planning pregnancy in 1 year following index procedure.
• Heavy calcification in lesion, defined as multiple persisting opacifications of the coronary wall visible in more than one projection surrounding the complete lumen of the coronary artery at the site of the lesion.
• Subject having serial lesions or diffuse disease with high probability of bailout requiring 3 or more stents in a single vessel.
• Stent overlapping is planned treatment at the target lesion.
• Subject needing other coronary vascular treatments next to the AdvaPro® DES which can affect the device performance.
• Impaired renal function (Creatinine >2.0 mg/dl or 180µmol/l)
• Subject with platelet count <100,000 or >700,000 cells/mm3
•Subject with WBC count <3,000 cells/mm3
• Subject with documented or suspected liver disease including laboratory evidence of Hepatitis.
• History of stroke (CVA) or transient ischemic attack (TIA) within last 3 months
• Subject with concomitant disease having a life expectancy of less than 12 months.
• Subject with cardiogenic shock
• Any significant medical condition which in investigator’s opinion may interfere with subject’s optimal participation in the study such as an active infection, peptic ulcer or upper GI bleeding.
• Subject with thrombocytopenia, neutropenia, or leukopenia
• History of bleeding diathesis, coagulopathy, or will refuse blood transfusions.
• Angiographic evidence of thrombus (larger than half the diameter of vessel and/or requiring other adjunctive intervention such as thrombolysis, Angio jet, etc.) in target vessel
• Target lesion within an arterial or saphenous vein graft anastomosis, distal to a diseased arterial or saphenous vein graft (visually estimated graft diameter stenosis greater than 40%)
• Extremely tortuosity proximal to or within the lesion
• Extreme angulation (90° or greater) proximal or within lesion
• Target lesion due to in-stent restenosis or a restenotic vessel from previous intervention
• Subject having undergone PCI within 48 hours of AMI episode.
• Subject with ongoing acute myocardial infarction (AMI)
• Subject with extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this clinical registry of AdvaPro® Sirolimus eluting coronary stent system is to demonstrate safety & effectiveness in treatment of patients with de novo coronary lesion in native coronary artery. <br/ ><br>The primary clinical endpoint is Target lesion failure (TLF), defined as cardiac death, target vessel nonfatal myocardial infarction (MI), & clinically driven target lesion revascularization (CD-TLR). <br/ ><br>All cause of death shall be considered cardiac unless a non-cardiac cause could be established clearly, either by clinical or pathological assessment / study. The primary endpoint will be reported after all subjects have completed 12 months (1 year) of follow-up. <br/ ><br>Timepoint: Patients will be followed up for 30 days, 6 months, & 12 months by telephone or scheduled outpatient clinic visit.
- Secondary Outcome Measures
Name Time Method