Advapro Coronary Stent System in Coronary Artery Diseased Patients. (RESTORE)

March 6, 2024 updated by: Advanced MedTech Solutions Pvt. Ltd.

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interventional
AdvaPro Sirolimus Eluting Coronary Stent System
Device: AdvaPro Sirolimus Eluting Coronary Stent System
Cardiac Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint
Time Frame: 1 Year
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of DOCE
Time Frame: 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
30 Days, 180 Days, 270 Days and 360 days
Incidence of POCE
Time Frame: 30 Days, 180 Days, 270 Days and 360 days
  1. All cause death
  2. Any Stroke
  3. Any myocardial infarction
  4. Any revascularization
30 Days, 180 Days, 270 Days and 360 days
Incidence of MACE
Time Frame: 30 Days, 180 Days and 360 days
  1. Cardiovascular Death
  2. Non-fatal MI
  3. Target Vessel Revascularization
30 Days, 180 Days and 360 days
Target vessel failure (TVF)
Time Frame: 30 Days, 180 Days, 270 Days and 360 days
Target vessel failure (TVF)
30 Days, 180 Days, 270 Days and 360 days
Non-Target Vessel related Myocardial Infarction
Time Frame: 30 Days, 180 Days, 270 Days and 360 days
Non-Target Vessel related Myocardial Infarction
30 Days, 180 Days, 270 Days and 360 days
Stent thrombosis
Time Frame: 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)
0-24 hours, 24 hours-30 days and late 30-365 days
Device success
Time Frame: 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
0 hour, 24 hours, 3 days
Procedural Success
Time Frame: 24 Hours
  • Residual Stenosis less than 20%
  • Successful reperfusion of Target vessel region with TIMI Flow ≥ 2
24 Hours
Acute Device Success
Time Frame: 24 Hours
Acute Device Success as defined by Residual Stenosis ≤ 20%
24 Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
For QCA Group
Time Frame: 270 Days
• Late Lumen Loss
270 Days
For QCA Group
Time Frame: 270 Days
• Angiographic binary restenosis
270 Days
For QCA Group
Time Frame: 270 Days
• In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS)
270 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced MedTech Solutions Pvt. Ltd.

Investigators

  • Principal Investigator: Dr Philippe Garot, Hôpital Privé Jacques Cartier, Massy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPL/PL/2023/004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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