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Novel Angioplasty Using Coronary Accessor (NAUSICA)

N

NAUSICA Investigators

Status

Completed

Conditions

Patency of the Radial Artery

Treatments

Procedure: PCI (percutaneous coronary intervention)

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00815997
2008-28

Details and patient eligibility

About

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.

Full description

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

6-Fr TRI (transradial coronary intervention)
Sham Comparator group
Description:
TRI will be performed using a 6-Fr guiding catheter.
Treatment:
Procedure: PCI (percutaneous coronary intervention)
4-Fr TRI
Active Comparator group
Description:
TRI will be performed using a 4-Fr guiding catheter.
Treatment:
Procedure: PCI (percutaneous coronary intervention)

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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