Not Yet RecruitingNot Applicable

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

2,000 participantsStarted 2025-08-18

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Target Lesion Failure (TLF)

Timeframe: 360 Days

Trial details

NCT IDNCT07098195

SponsorPoly Medicure Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-17

Contact for this trial

Dinesh Rajendra Patil

+91-8149037128 dinesh.patil@polymedicure.com

View on ClinicalTrials.gov More Coronary Artery Disease trials