Study to evaluate safety and efficacy of FOCUSnp Sirolimus based nano carrier eluting coronary stent system for treatment of patients with single de novolesions in native coronary artery lesions. - NANOACTIVE FIM-I

Envision Scientific Pvt Ltd0 sites100 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Envision Scientific Pvt Ltd
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

Envision Scientific Pvt Ltd

Eligibility Criteria

Inclusion Criteria

•1\.De novo lesions in native coronary arteries.
•2\.Reference diameter is greater than 2\.50 and is less than or equal to 3\.50 mm (visual estimation).
•3\.Lesion length 10 mm less than or equal to Lesion Length is less than or equal to 24 mm (visual estimation).
•4\.Single lesion per vessel.
•5\.Maximum two lesions per patient.
•6\.All lesions must be treated with the same study device (FOCUSnp•).
•7\.The patient is at least 18 years of age.
•8\.The patient has clinical evidence of ischemic heart disease,stable or unstable angina,silent ischemia,or a positive functional trial.
•9\.The patient is an acceptable candidate for percutaneous trans luminal coronary angioplasty (PTCA),stenting,and emergent coronary artery bypass graft (CABG) surgery.
•10\.Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.

Exclusion Criteria

•1\.Bifurcation lesion(s) including left main,Target lesion with Ostial location (within 5 mm of Ostium by visual assessment),Target lesion with lateral side branch is greater than 2\.5 mm or requiring lateral branch stenting.
•2\.Moderate to severely calcified lesions(visual estimation)
•3\.Severe tortuous lesions or with proximal angulation (greater than 90 degrees) or at a greater than 45 degree bend in the vessel.
•4\.Documented left ventricular ejection fraction (LVEF) less than 30 percent at most recent evaluation.
•5\.A known hypersensitivity or contraindication to aspirin,heparin or bivalirudin,Ticlopidine or clopidogrel,cobalt chromium or stainless steel alloys,polymer coatings,contrast media,which cannot be adequately pre\-medicated.
•6\.History of an allergic reaction or significant sensitivity to Sirolimus or drugs in similar class.
•7\.Chronic total occlusion (CTO) or Presence of visible thrombus in target vessel.
•8\.A serum creatinine level greater than 2\.0 mg/dl within seven days prior to index procedure.
•9\.Evidence of an acute MI within 72 hours of the intended index procedure (defined as: QWMI or non\-Q wave myocardial infarction (NQWMI) having CK enzymes greater than 2X the upper laboratory normal with the presence of a CK\-MB elevated above the Institutionâ??s upper limit of normal).
•10\. Platelet Count less than 1000,000 cells/mm3 or greater than 700,000 cells/mm3,White blood cell count 3,000 cell/mm3,Hepatic disease(suspected or documented including laboratorial evidence of hepatitis).