Clinical trial NCT06300268: Advapro Coronary Stent System in Coronary Artery Diseased Patients.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
De Novo Stenosis Lesion
Coronary Stent Implantation
Keywords: AdvaPro Sirolimus Eluting Coronary Stent System
Late lumen loss
Advanced Medtech Solutions
QCA
PTCA
Lead sponsor: Advanced MedTech Solutions Pvt. Ltd.
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study (Open Label)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Endpoint
timeFrame: 1 Year
Secondary outcomes:
measure: Incidence of DOCE
timeFrame: 30 Days, 180 Days, 270 Days and 360 days
measure: Incidence of POCE
timeFrame: 30 Days, 180 Days, 270 Days and 360 days
measure: Incidence of MACE
timeFrame: 30 Days, 180 Days and 360 days
measure: Target vessel failure (TVF)
timeFrame: 30 Days, 180 Days, 270 Days and 360 days
measure: Non-Target Vessel related Myocardial Infarction
timeFrame: 30 Days, 180 Days, 270 Days and 360 days
measure: Stent thrombosis
timeFrame: 0-24 hours, 24 hours-30 days and late 30-365 days
measure: Device success
timeFrame: 0 hour, 24 hours, 3 days
measure: Procedural Success
timeFrame: 24 Hours
measure: Acute Device Success
timeFrame: 24 Hours
Other outcomes:
measure: For QCA Group
timeFrame: 270 Days
measure: For QCA Group
timeFrame: 270 Days
measure: For QCA Group
timeFrame: 270 Days
Locations:
Study officials:
affiliation: Hôpital Privé Jacques Cartier, Massy
name: Dr Philippe Garot
role: PRINCIPAL_INVESTIGATOR
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