Safety and Performance of the Relisys Pre-dilatation catheters in Coronary Angiography.

QUIN-SC: A retrospective, open-label, non - randomized, post-market clinical follow up study to assess the safety and performance of the Relisys Pre-dilatation catheters in human subjects who underwent coronary angioplasty. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/062921

Enrollment

261

Registered

2024-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I708- Atherosclerosis of other arteries

Interventions

Intervention1: Pre-dilatation Catheter: The Pre-dilatation balloon catheter is used for predilatation of the coronary arteries Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1.The patient must be 18 years of age or older, irrespective of gender. 2.Subjects who underwent treatment with stenotic lesions in coronary arteries or bypass graft stenosis for percutaneous coronary intervention (PCI). 3. The patient had single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and, or a positive functional study. 4. Underwent treatment with Relisys Pre-dilatation catheters during the period Jan 2019 to Dec 2023. 5. The subject must have denovo or restenotic lesions in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. 6. A maximum of three lesions, including must be in different coronary arteries or bypass grafts. 7. The target lesions must have a diameter stenosis greater than 70 percentage by visual estimation and be amenable to percutaneous intervention.

Exclusion criteria

Exclusion criteria: 1.Pregnant Female. 2.Presence of any known life-threatening noncardiac(major or progressive) disease that will limit the patients life expectancy. 3.Documented evidence of significant renal dysfunction(serum creatinine less than 3.0mg per dl) or on any form of dialysis. 4. Psychiatric or behavioral disease, including known alcohol or drug abuse ( continued use of alcohol, illegal drugs, or the misuse of prescription or the OTC drugs with negative physical or psychological consequences). 5. Subjects who have known hypersensitivity to device materials. 6. The patient has any other concurrent conditions that, in the opinion of the investigator, may compromise patient safety, privacy, and study objectives.

Design outcomes

Primary

Measure	Time frame
To assess the safety of Relisys Pre-dilatation catheter in patients.Timepoint: Baseline	—

Secondary

Measure	Time frame
To assess the performance of Relisys Pre-dilatation catheter in patients.Timepoint: Baseline	—

Countries

India

Contacts

Public ContactDr Sneha Voruchu

Relisys Medical Devices Limited

Snehav@relisys.in9618080999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026