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Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

NCT02269449 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2014-10-21

No results posted yet for this study

Summary

The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).

Conditions

  • Percutaneous Coronary Intervention

Interventions

DEVICE

6Fr Glidesheath Slender sheath

6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.

DEVICE

5Fr sheath

5Fr Hydrophilic coating sheath from Terumo.

PROCEDURE

Hemostasis with TR band

Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.

PROCEDURE

Any hemostasis procedure

Hemostasis is achieved by any hemostasis of each hospital's routine procedure.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Duke Clinical Research Institute

    collaborator OTHER

  • NPO International TRI Network

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

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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 NCT02269449 on ClinicalTrials.gov