Coronary Artery Disease, Coronary Stent Implantation, De Novo Stenosis Lesion
Conditions
Keywords
AdvaPro Sirolimus Eluting Coronary Stent System, Late lumen loss, Advanced Medtech Solutions, QCA, PTCA
Brief summary
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population. To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months. Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit. A QCA Analysis will be performed on minimum 48 patients in Indian population only. Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.
Detailed description
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population(RESTORE). A QCA Analysis will be performed on minimum 48 patients in Indian population only at baseline visit and 9 month follow-up. Interval(Days) for patients visit at Day 0, Day 30±7, Day 180±8, Day 270±10 and Day 360±14. Sample size distribution: Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. Primary Objective: To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months. Secondary Objectives: To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30, 180, 360 days and device oriented composite end point (DOCE), patient oriented composite end point (POCE) Stent Thrombosis, Target vessel failure (TVF), Target Vessel related Myocardial Infarction (TV-MI), and individual components of composite end points at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent. To estimate device and procedure success at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent. To Estimate Definitive parameters of performance of AdvaPro Sirolimus Eluting Stent as defined by Late Lumen Loss and Diameter Stenosis percentage at 270 days of AdvaPro Sirolimus Eluting Stent. Exploratory objectives: None Stent is approved for manufacturing and marketing in India.
Interventions
DEVICEAdvaPro Sirolimus Eluting Coronary Stent System
Cardiac Stent
Sponsors
Advanced MedTech Solutions Pvt. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot Study (Open Label)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Gender : All (Males, Females, Transgenders, Non-binary) * ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form. * Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI) * Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70% * Condition - Angiographic : Patients with Reference vessel diameter of 2.5 \ 3.50 mm * Condition - Angiographic : Patients with lesion length ≤ 36 mm
Exclusion criteria
* Ethical : Pregnant and lactating females * Patients requiring staged procedure * Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30% * Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media * Condition : Current medical condition with a life expectancy of less than 12 months * Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure * Condition : Patient has current unstable arrhythmias * Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization * Procedural : Patients with Chronic Total Occlusion in two or more vessels * Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin). * Procedural : Patients with Bifurcation lesions that include a side branch \>2.0 mm diameter * Procedural : Unprotected Left Main Coronary Artery lesion * Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist * Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine \>2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure * Condition : Patients with platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | 1 Year | MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DOCE | 30 Days, 180 Days, 270 Days and 360 days | 1. Cardiovascular Death 2. Myocardial infarction in the territory of Target vessel 3. Clinically driven target lesion revascularization |
| Incidence of POCE | 30 Days, 180 Days, 270 Days and 360 days | 1. All cause death 2. Any Stroke 3. Any myocardial infarction 4. Any revascularization |
| Incidence of MACE | 30 Days, 180 Days and 360 days | 1. Cardiovascular Death 2. Non-fatal MI 3. Target Vessel Revascularization |
| Target vessel failure (TVF) | 30 Days, 180 Days, 270 Days and 360 days | Target vessel failure (TVF) |
| Stent thrombosis | 0-24 hours, 24 hours-30 days and late 30-365 days | Stent thrombosis as per 1. Academic Research Consortium \[ARC\] Evidence definitions - Definite and probable 2. As per latency - Acute (0-24 hours), Subacute (24 hours-30 days) and late (30-365 days) |
| Device success | 0 hour, 24 hours, 3 days | * Residual coronary stenosis less than 20% * Normal coronary flow and absence of coronary dissections \> C * Procedural and absence of PCI complications including periprocedural MI, coronary perforation, urgent CABG or death or revascularization within 3 days of Index procedure |
| Procedural Success | 24 Hours | * Residual Stenosis less than 20% * Successful reperfusion of Target vessel region with TIMI Flow ≥ 2 |
| Acute Device Success | 24 Hours | Acute Device Success as defined by Residual Stenosis ≤ 20% |
| Non-Target Vessel related Myocardial Infarction | 30 Days, 180 Days, 270 Days and 360 days | Non-Target Vessel related Myocardial Infarction |
Other
| Measure | Time frame | Description |
|---|---|---|
| For QCA Group | 270 Days | • Late Lumen Loss |
Contacts
Primary ContactDr Jayesh Jani
Backup ContactPriyadarshini Arambam
Outcome results
None listed