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Ultrasound Comparison of Radial Artery Hyperplasia After Use of a 7F Sheathless Guide vs. 6F Sheath/Guide Combination

NCT03271177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-09-01

No results posted yet for this study

Summary

The purpose of this study is to determine if the routine use of a sheathless 7F guide catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F sheath/guide combination with regards to radial artery injury (radial artery intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution ultrasonography (55 mHz) will be used to accurately quantify radial artery intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority analysis will be performed to compare the degree of radial artery IMT at 90 days between the 7F sheathless guide approach and the 6F sheath/guide combination.

Conditions

Interventions

DEVICE

7F sheathless Guide Catheter

Transradial PCI will be performed with a 7F sheathless Guide Catheter

DEVICE

6F Sheath/Guide Catheter Combination

Transradial PCI will be performed with a 6F Sheath/Guide Catheter Combination

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Tallahassee Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Wayne B Batchelor, MD, MHS · Tallahassee Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-25
Primary Completion
2017-03-13
Completion
2017-03-13

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Entities

Diseases

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 NCT03271177 on ClinicalTrials.gov