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Chronic Total Occlusion Percutaneous Coronary Intervention Study

NCT03988166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-09-28

Study results available
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Summary

The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.

Conditions

  • Chronic Total Occlusion
  • Ischemic Heart Disease
  • Chronic Total Occlusion of Coronary Artery

Interventions

PROCEDURE

Chronic Total Occlusion Revascularization

Teleflex's series of study guidewires and catheters will be used to facilitate the safe and effective crossing of de novo CTOs and placement of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway.

DEVICE

GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

Sponsors & Collaborators

  • Teleflex

    collaborator INDUSTRY

  • Bright Research Partners

    collaborator INDUSTRY

  • Vascular Solutions LLC

    lead INDUSTRY

Principal Investigators

  • David E Kandzari, MD · Piedmont Heart Institute

  • Dimitrios Karmpaliotis, MD, PhD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2021-02-22
Completion
2021-02-22
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 NCT03988166 on ClinicalTrials.gov