A Prospective, Active control, open label, Multicentre Randomized Clinical Trial for comparison between BioMime Sirolimus Eluting Stent, or Meril Life Sciences and Xience Everolimus Eluting stent or Family of Abbott Vascular Inc.. to Evaluate Efficacy and Safety in Coronary Artery Disease
- Conditions
- Heart disease10011082
- Registration Number
- NL-OMON41944
- Lead Sponsor
- Meril Life Sciences Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
* The subjects must be >= 18 years of age.
* Clinical evidence of ischemic heart disease and / or a positive territorial functional study.
- Documented stable angina (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4 )
or
- Documented unstable angina with documented ischemia (Braunwald Class IB-C, C-IIB, IIIB or C),
or
- Documented silent ischemia
* The subject having a planned intervention or up to two de novo native lesions
* Target lesion reference diameter >= 2.5 mm and <= 3.5 mm (visually estimated)
* The target lesion length is less than or equal to 46 mm (visually estimated)
* Subjects willing to providence written informed consent.
* Female subjects without childbearing potential who have either undergone surgical sterilization or is postmenopausal.
* The subject and the subject's physician agree to the follow-up visits-including a 9 month angiographic followup.
* Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours Preceding the index procedure, Unless the CK and CK-MB enzymes are less than twice the Upper Limit Normal.
* The subjects who have a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus or the contrast media
* There is an untreated significant lesion or> 40% diameter stenosis proximal or distal to the remaining target site after the planned intervention.
* Previous PCI with stent placement or any at the target lesion and / or within 10 mm of the target lesion.
* Lesion with a significant side branch (branch diameter > 2 mm) thatwould be covered by Stenting
* Total occlusion or coronary TIMI 0 flow in the target vessel.
* Left main coronary artery disease.
* The proximal target vessel or target lesion is severely calcified by visual assessment.
aorto-ostial * location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
* The subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* The subject Suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleeds within the past 6 months
* The subject has renal insufficiency as Determined by a creatinine of> 2mg/dl or 180 mg / dl.
* The target lesion, or the target vessel proximal to the target lesion contains thrombus
* Documented left ventricular ejection fraction of <= 30%
* The subject is a recipient of a transplant surgery (Heart, Kidney, Liver etc)
* The patient has extensive peripheral vascular disease That precludes safe 6 French sheath insertion
* Extreme angulations of the vessel at access location (<45 degrees)
* The subject has other medical illness (zoals cancer or congestive heart failure) That May cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (ie less than one year)
* The patient is simultaneously participant participating in another investigational drug or device study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>The primary endpoint of this study is to assess in-stent Late Lumen Loss at 9<br /><br>months for both treatment strategies. Late lumen loss is defined as the<br /><br>difference in minimal luminal diameter (MLD) between post-procedural and follow<br /><br>up MLD in mm.<br /><br>The Analysis of primary endpoints is performed on basis of the evaluation of<br /><br>the angiography images by an independent core laboratory.</p><br>
- Secondary Outcome Measures
Name Time Method