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Registry of RESOLUTE-ONYX™ Zotarolimus-eluting Stent Utilization in Percutaneous Small Vessel Coronary Interventionism.

NCT04785846 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 307

Last updated 2021-03-10

No results posted yet for this study

Summary

DESIGN: Prospective, single-arm, multicenter, observational, prospective registry of the use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous coronary intervention in small vessels.

Clinical follow-up at 1 month, 6 months and 1 year.

OBJECTIVE: To evaluate the safety and efficacy of using RESOLUTE-ONYX zotarolimus-eluting stent in PCI in small vessels (diameter ≤2.5 mm).

DISEASE UNDER STUDY: Adult patients with coronary artery disease (stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome) undergoing percutaneous coronary intervention on vessels with a diameter less than or equal to 2.5 mm.

TOTAL NUMBER OF PATIENTS: Approximately 320 patients are expected to be included in the study.

Conditions

  • Coronary Disease
  • Angina, Stable
  • Ischemia
  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention

Interventions

DEVICE

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention

Sponsors & Collaborators

  • Fundación Investigación Sanitaria en León

    lead OTHER

Principal Investigators

  • Carlos Cuellas Ramón, MD · Fundación de Investigación Sanitaria de León

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2020-02-17
Completion
2020-02-17
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785846 on ClinicalTrials.gov