N/A
N=160
Novel Angioplasty Using Coronary Accessor
Patency of the Radial Artery
Bottom Line
View on ClinicalTrials.gov: NCT00815997 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Patients With Radial Artery Occlusion — 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PCI (percutaneous coronary intervention) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NAUSICA Investigators
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Radial Artery Occlusion |
3; 0 | — |
| SECONDARY Number of Patients With Successful PCI |
79; 79 | — |
| SECONDARY Number of Patients With Measure Adverse Cardiac Event (MACE) |
0; 0 | — |
| SECONDARY Number of Patients With Access-site Complications |
5; 0 | — |
| SECONDARY Fluoroscopy Time Used for the Procedure |
12; 13 | — |
| SECONDARY Contrast Dye Volume Used for the Procedure |
101; 87 | — |
| SECONDARY Time Used for the Procedure |
37; 37 | — |
| SECONDARY Time Used for Hemostasis |
320; 237 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00815997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.