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Completed

NCT Number: NCT00815997

Novel Angioplasty Using Coronary Accessor

To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of radial artery occlusion after transradial coronary intervention (TRI) will be evaluated. Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr groups.

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Key information

Conditions

Patency of the Radial Artery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Hospital, Hyderabad, Andhra Pradesh, India

Loading trial locations.

About this study

Prerequisites for TRI were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test. Exclusion criteria for the current study included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.

Patency of the radial artery after TRI will be evaluated by pulsation of the radial artery, and frequencies of which will be compared between those receiving 4Fr vs 6 Fr coronary interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prerequisites for transradial intervention were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test.

Exclusion criteria

  • Exclusion criteria included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.

Treatment and study plan

PCI (percutaneous coronary intervention)

Procedure

PCI will be performed via the radial artery.

Primary outcomes

  1. Number of Patients With Radial Artery Occlusion

    Time frame: within 2 days after TRI

    The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.

Secondary outcomes

  1. Number of Patients With Successful PCI

    Time frame: within 2 days after TRI

    Procedural success was defined as a postprocedural residual stenosis of less than 20%, and a thrombolysis in myocardial infarction (TIMI) grade 3 angiographic flow without MACE during in-hospital follow-up.

  2. Number of Patients With Measure Adverse Cardiac Event (MACE)

    Time frame: within 2 days after TRI

    Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization

  3. Number of Patients With Access-site Complications

    Time frame: within 2 days after TRI

    Access-site-related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion.

  4. Fluoroscopy Time Used for the Procedure

    Time frame: At the end of TRI

    Fluoroscopy time used for the procedure (minutes).

  5. Contrast Dye Volume Used for the Procedure

    Time frame: At the end of TRI

    Contrast dye volume used for the procedure (mL).

  6. Time Used for the Procedure

    Time frame: At the end of TRI

    Time used for the procedure (minutes).

  7. Time Used for Hemostasis

    Time frame: within 2 days afterTRI

    Time Used for Hemostasis (minutes).

Sponsors and collaborators

Lead sponsor

NAUSICA Investigators

Network

Collaborators

  • NPO International TRI Network

Registry information

Acronym: NAUSICA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 31, 2008
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.