To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System

NCT07098195 | Not Yet Recruiting DMC

• 1 other identifier: CSPL/REG/2025/02
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Percutaneous Coronary Intervention; de Novo Lesions in Native Coronary Arteries

Keywords

RisoR Crest; Everolimus Eluting Stent; Poly Medicure Private Limited; Drug Eluting Stent; Biodegradable Polymer; Pacifier

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, Target Vessel oriented Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.

  360 Days

Secondary Outcomes (8)

• Incidence of TLF (Equivalent of DoCE)

  30, 180 and 270 days

• Incidence of POCE

  30, 180, 270 and 360 days

• Incidence of MACE

  30, 180, 270 and 360 days

• Target Vessel Failure (TVF)

  30, 180, 270 and 360 days

• Non -Target Vessel related Myocardial Infarction

  30, 180, 270 and 360 days

Other Outcomes (9)

• QCA Endpoints

  270 days

• QCA Endpoints

  270 days

• QCA Endpoints

  270 Days

Study Arms (1)

RisoR Crest Everolimus Eluting Coronary Stent System

OTHER

The RisoR Crest Everolimus Eluting Coronary Stent System is coated with a drug and biodegradable polymer coating formulation consisting of Everolimus drug, the active ingredient, and biodegradable polymers. This is intended to supply continuous release of Everolimus drug after stent implantation over an extended period of time. The unique ultrasonic atomization drug technology is combined with acoustic activation and carrier stream technologies.

Device: Coronary Stent

Interventions

Coronary Stent DEVICE

RisoR Crest Everolimus Eluting Coronary Stent System

RisoR Crest Everolimus Eluting Coronary Stent System

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years
• All Genders (Males, Females, Transgenders, Non binary)
• Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
• Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)
• Patient with coronary artery disease having one or more de novo or in - stent stenosis lesions in native coronary artery with a visually estimated diameter stenosis ≥70%.
• Patients with Reference vessel diameter of 2.0 to 4.5 mm
• Patients with lesion length less than 48 mm

You may not qualify if:

• Pregnant and lactating females
• Candidates for emergency bypass Surgery
• Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)
• Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
• Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
• Current medical condition with a life expectancy of less than 12 months
• Patient who have current unstable arrhythmias
• Patient previously undergone CABG.
• Left Main Coronary Artery lesion
• Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine \>2.0mg/dl or 150 μmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure
• Patients with platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3

Sponsors & Collaborators

• Poly Medicure Limited: lead

Related Publications (16)

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Related Links

• World Heart Report 2023: Confronting the World's Number One Killer.
• Cardiovascular diseases statistics
• India Coronary Stents Market. Coherent Market Insights
• Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2
• CSI: Cardiology Update 2014
• The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts
• MEDICAL DEVICES RULES, 2017
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/E

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dr. Praveen Chandra, DM Cardiology

  Medanta-The Medicity, Gurugram, Haryana, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinesh Rajendra Patil

CONTACT

+91-8149037128; dinesh.patil@polymedicure.com

Priyadarshini Arambam

CONTACT

+91-9910990347; regulatory@clicebo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-market study in India and Pre-market study in Europe.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: August 1, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): January 17, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share