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NCT03988166 · ClinicalTrials.gov registry record · NA

Chronic Total Occlusion Percutaneous Coronary Intervention Study

A NA study of Ischemic Heart Disease and Chronic Total Occlusion of Coronary Artery, sponsored by Vascular Solutions.

Completed
Registry status
NA
Development phase
150
Enrollment target
13
Study locations

NCT03988166: Completed NA study of Ischemic Heart Disease and Chronic Total Occlusion of Coronary Artery, sponsored by Vascular Solutions.

NCT03988166 is a NA study of Ischemic Heart Disease and Chronic Total Occlusion of Coronary Artery that has completed, run by Vascular Solutions. The registered enrollment target is 150 participants, below the 256-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (41% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03988166, a NA study of Ischemic Heart Disease and Chronic Total Occlusion of Coronary Artery, has completed, sponsored by Vascular Solutions.

COMPLETED
Registry status
NA
Development phase
150 participants
Enrollment target
13
Study locations

Study 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.

Primary Outcome

Defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). • MACE defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (MI) (Q-wave or non-Q-wave, with creatine kinase (CK) with Muscle (M)-Brain (B) subunits \> 3 ULN).

Interventions

  • PROCEDURE Chronic Total Occlusion Revascularization
  • DEVICE GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

Study Locations (13)

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

Georgia

  • Piedmont Heart Institute - Atlanta
  • Emory University - Atlanta

New York

  • NYU Langone Health - New York
  • Columbia University Medical Center - New York

California

  • Torrance Memorial Medical Center - Torrance

Michigan

  • Henry Ford Hospital - Detroit

Minnesota

  • Minneapolis Heart Institute Foundation - Minneapolis

Missouri

  • Missouri Cardiovascular Specialists - Columbia

Ohio

  • The Christ Hospital - Cincinnati

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2020-05-20
Est. Completion 2021-02-22
Phase NA
Vascular Solutions

7 total trials

What the finished NCT03988166 record still lists

NCT03988166 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (41% lower).

The record links to 3 conditions, with Ischemic Heart Disease appearing as the primary indexed condition, and to 2 interventions - of which Chronic Total Occlusion Revascularization is the first listed.

NCT03988166 lists 13 locations in 9 states (Massachusetts, Georgia, New York).

Frequently Asked Questions

What is clinical trial NCT03988166 about?

NCT03988166 is a clinical study titled "Chronic Total Occlusion Percutaneous Coronary Intervention Study". 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.

What is the current status of trial NCT03988166?

This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2020-05-20. Estimated completion is 2021-02-22.

What conditions does trial NCT03988166 study?

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

What interventions are being tested in trial NCT03988166?

The interventions under investigation include: Chronic Total Occlusion Revascularization (PROCEDURE), GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter (DEVICE).

Who is sponsoring clinical trial NCT03988166?

This trial is sponsored by Vascular Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03988166 being conducted?

This trial has 13 study locations across California, Georgia, Massachusetts, Michigan, Minnesota. 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 NCT03988166's enrollment target sits among peer trials

150 5th of 14 higher than 9 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 NCT03988166, the US trial registry maintained by the National Library of Medicine. NCT03988166 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.