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A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

NCT01186198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2023-11-13

Study results available
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Summary

This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.

Conditions

  • Ischemic Heart Disease
  • Coronary Artery Stenosis
  • Chronic Coronary Total Occlusion
  • Coronary Bypass Graft Stenosis

Interventions

DEVICE

MINI TREK RX 1.20 mm Coronary Dilatation Catheter

Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • David E Kandzari, MD · Piedmont Heart Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-12
Primary Completion
2010-12-30
Completion
2010-12-30
FDA Device
Yes

Countries

  • United States

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 NCT01186198 on ClinicalTrials.gov