NCT07098195Not yet recruiting
To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System
An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and Safety of RIsoR Crest EveRolimus Eluting Coronary Stent System
Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 12 Jul 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 17 Aug 2027
- Lead sponsor
- Poly Medicure Limited
- Diseases
- Coronary artery disease
- NCT number
- NCT07098195
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 18 Aug 2025 to the primary completion date, 17 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Candidates for emergency bypass Surgery
- Patient previously undergone CABG.
Other illness
- 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.)
- 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
Lab values
- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
- 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
Other
- Pregnant and lactating females
- Left Main Coronary Artery lesion
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.