Health Condition 1: null- Patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenoses that are amenable to percutaneous treatment.
Conditions
Interventions
None listed
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age ≥18 years or minimum age as required by local regulations ? The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Declaration of Helsinki. ? Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the?Instructions for Use? that comes with every Medtronic Resolute Integrity stent system. ? Intended implantation of the Resolute Integrity stent either as primary or secondary cross-over stent following a delivery failure of another stent type. ? The patient (or legal representative) has been informed of the nature of the study and has consented to participate and authorized the collection and release of their medical information by signing a consent form (?Patient Informed Consent Form? or ?Patient Data Release Authorization Form?).
Exclusion criteria
Exclusion criteria: Pregnancy ? Patient is participating in another study that interferes with the study endpoints ? Patients with untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, zotarolimus or similar drugs or contrast media. ? Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.Timepoint: Till discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success Lesion Success Procedure Success Resource Utilization: procedure time (min), contrast volume used (ml), usage of guiding catheters, guide wires and angioplasty balloons. Acute deliverability parameters (overall deliverability, pushability, trackability, crossability, ability to recross a lesion or stent, stent radiopacity, stent recoil, side branch access, conformability, overall performance) In-hospital MACE In-hospital Target Lesion Failure (TLF)Timepoint: Till discharge | — |
Countries
Australia, Austria, Bangladesh, Belgium, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Morocco, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt Ltd
Outcome results
None listed