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NCT01186198 · ClinicalTrials.gov registry record

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

A clinical trial of Ischemic Heart Disease and Coronary Artery Stenosis, sponsored by Abbott Medical Devices.

Completed
Registry status
71
Enrollment target
4
Study locations

NCT01186198: Completed study of Ischemic Heart Disease and Coronary Artery Stenosis, sponsored by Abbott Medical Devices.

NCT01186198 is a study of Ischemic Heart Disease and Coronary Artery Stenosis that has completed, run by Abbott Medical Devices. The registered enrollment target is 71 participants, below the 261-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01186198, a study of Ischemic Heart Disease and Coronary Artery Stenosis, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
71 participants
Enrollment target
4
Study locations

Study 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.

Primary Outcome

Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK

Interventions

  • DEVICE MINI TREK RX 1.20 mm Coronary Dilatation Catheter

Study Locations (4)

California

  • Scripps Green Hospital - La Jolla

Maryland

  • Peninsula Regional Medical Center - Salisbury

Michigan

  • Northern Michigan Hospital - Petoskey

Ohio

  • The Christ Hospital - Cincinnati

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2010-08-12
Est. Completion 2010-12-30
Abbott Medical Devices

261 total trials

What the finished NCT01186198 record still lists

NCT01186198 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 261-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (73% lower).

The record links to 4 conditions, with Ischemic Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which MINI TREK RX 1.20 mm Coronary Dilatation Catheter is the first listed.

NCT01186198 reports a single indexed study location in California, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT01186198 about?

NCT01186198 is a clinical study titled "A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions". 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 ...

What is the current status of trial NCT01186198?

This trial is currently completed. The enrollment target is 71 participants. The study started on 2010-08-12. Estimated completion is 2010-12-30.

What conditions does trial NCT01186198 study?

This clinical trial studies the following conditions: Ischemic Heart Disease, Coronary Artery Stenosis, Coronary Bypass Graft Stenosis, Chronic Coronary Total Occlusion.

What interventions are being tested in trial NCT01186198?

The interventions under investigation include: MINI TREK RX 1.20 mm Coronary Dilatation Catheter (DEVICE).

Who is sponsoring clinical trial NCT01186198?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01186198 being conducted?

This trial has 4 study locations across California, Maryland, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ischemic Heart Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01186198's enrollment target sits among peer trials

71 9th of 14 higher than 6 of 14 other Ischemic Heart Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ischemic Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01186198, the US trial registry maintained by the National Library of Medicine. NCT01186198 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.