Patency of the Radial ArteryNAUSICANCT00815997
Novel Angioplasty Using Coronary Accessor
A study testing PCI (percutaneous coronary intervention) in people with Patency of the Radial Artery, run by NAUSICA Investigators at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patency of the Radial Artery
- What is being tested?
- PCI (percutaneous coronary intervention)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 1 Jan 2009to 31 Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Japan16 sites
Aomori Prefectural Central Hospital
Aomori, 030-8553
Shonan Atsugi Hospital
Atsugi, Kanagawa, 243-8551
Fukuoka Heart Clinic
Fukuoka, 813-0036
Tokai University
Isehara, Kanagawa, 259-1193
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Sakurakai Takahashi Hospital
Kobe, Hyōgo, 654-0026
Shin-Koga Hospital
Kurume, Fukuoka, 830-8577
Kyoto Kujo Hospital
Kyoto, 601-8453
Chibaken Saiseikai Narashino Hospital
Narashino, Chiba, 275-0006
Hyogo College of Medicine
Nishinomiya, Hyōgo, 665-8501
Kin-ikyo Central Hospital
Sapporo, Hokkaido, 007-8505
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033
Tosei General Hospital
Seto, Aichi-ken, 489-8652
Jichi Medical University
Shimotsuke, Tochigi, 329-0498
Kumamoto Rosai Hospital
Yatsushiro, Kumamoto, 866-8533
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
India2 sites
Global Hospital
Hyderabad, Andhra Pradesh
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, 500003
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Patency of the Radial Artery
- Being tested
- PCI (percutaneous coronary intervention)
- Keywords
- radial artery, transradial intervention, stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI (percutaneous coronary intervention)Procedure or surgery
PCI will be performed via the radial artery.
| Study group | Role | What they receive |
|---|---|---|
| 6-Fr TRI (transradial coronary intervention) | Sham comparator | TRI will be performed using a 6-Fr guiding catheter. Receives: Procedure: PCI (percutaneous coronary intervention) |
| 4-Fr TRI | Active comparator | TRI will be performed using a 4-Fr guiding catheter. Receives: Procedure: PCI (percutaneous coronary intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Radial Artery Occlusion
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.
Measured: within 2 days after TRI
Secondary outcomes (7)
Number of Patients With Successful PCI
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.
Measured: within 2 days after TRI
Number of Patients With Measure Adverse Cardiac Event (MACE)
Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization
Measured: within 2 days after TRI
Number of Patients With Access-site Complications
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.
Measured: within 2 days after TRI
Fluoroscopy Time Used for the Procedure
Fluoroscopy time used for the procedure (minutes).
Measured: At the end of TRI
Contrast Dye Volume Used for the Procedure
Contrast dye volume used for the procedure (mL).
Measured: At the end of TRI
Time Used for the Procedure
Time used for the procedure (minutes).
Measured: At the end of TRI
Time Used for Hemostasis
Time Used for Hemostasis (minutes).
Measured: within 2 days afterTRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study start1 Jan 2009
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patency of the Radial ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- NAUSICA Investigators
- Sponsor type
- Research network
- Collaborators
- NPO International TRI Network
- Responsible party
- Principal investigator, Shigeru Saito, NAUSICA Investigators
- Investigators
- Shigeru Saito, MD, Principal investigator, Vice Preseident, Shonan Kamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815997
- Sponsor's protocol ID
- 2008-28
- Acronym
- NAUSICA
- Status last verified
- Feb 2019
- First submitted
- 29 Dec 2008
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Takeshita S, Asano H, Hata T, Hibi K, Ikari Y, Kan Y, Katsuki T, Kawasaki T, Masutani M, Matsumura T, Premchand RK, Rao SP, Suzuki T, Takahashi A, Takeda R, Tanaka S, Yamazaki S, Yin WH, Yoshimachi F, Saito S; NAUSICA Trial Investigators. Comparison of frequency of radial artery occlusion after 4Fr versus 6Fr transradial coronary intervention (from the Novel Angioplasty USIng Coronary Accessor Trial). Am J Cardiol. 2014 Jun 15;113(12):1986-9. doi: 10.1016/j.amjcard.2014.03.040. Epub 2014 Apr 1.
PubMed 24786357
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Angioplasty USIng Coronary Accessor
- ClinicalTrials.gov ID
- NCT00815997
- Acronym / sponsor ID
- NAUSICA / 2008-28
- Conditions
- Patency of the Radial Artery
- Keywords
- radial artery, transradial intervention, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- NAUSICA InvestigatorsResearch network
- Collaborators
- NPO International TRI Network
- Study start
- 1 Jan 2009
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-Fr TRI (transradial coronary intervention) | Sham comparator | Procedure: PCI (percutaneous coronary intervention)TRI will be performed using a 6-Fr guiding catheter. |
| 4-Fr TRI | Active comparator | Procedure: PCI (percutaneous coronary intervention)TRI will be performed using a 4-Fr guiding catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI (percutaneous coronary intervention)PCI will be performed via the radial artery. | Procedure or surgery | 4-Fr TRI, 6-Fr TRI (transradial coronary intervention) |
Primary outcome
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.
7 secondary outcomes
Number of Patients With Successful PCI
Time frame: within 2 days after TRI
Number of Patients With Measure Adverse Cardiac Event (MACE)
Time frame: within 2 days after TRI
Number of Patients With Access-site Complications
Time frame: within 2 days after TRI
Fluoroscopy Time Used for the Procedure
Time frame: At the end of TRI
Contrast Dye Volume Used for the Procedure
Time frame: At the end of TRI
Time Used for the Procedure
Time frame: At the end of TRI
Time Used for Hemostasis
Time frame: within 2 days afterTRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24786357Takeshita S, Asano H, Hata T, Hibi K, Ikari Y, Kan Y, Katsuki T, Kawasaki T, Masutani M, Matsumura T, Premchand RK, Rao SP, Suzuki T, Takahashi A, Takeda R, Tanaka S, Yamazaki S, Yin WH, Yoshimachi F, Saito S; NAUSICA Trial Investigators. Comparison of frequency of radial artery occlusion after 4Fr versus 6Fr transradial coronary intervention (from the Novel Angioplasty USIng Coronary Accessor Trial). Am J Cardiol. 2014 Jun 15;113(12):1986-9. doi: 10.1016/j.amjcard.2014.03.040. Epub 2014 Apr 1.
Related trials for Patency of the Radial Artery
Recruiting
Retrograde Ascending Dissection: Intraluminal Aortic Therapy
Ascending Aortic Dissection
Recruiting
One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG
Cardiac Disease, Surgery-Complications
Not yet recruiting
Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
Hemostasis of Arterial Punctures
Not yet recruiting
Radial Artery Versus No-touch Saphenous Vein
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Saito, MD principal investigator
Vice Preseident, Shonan Kamakura General Hospital
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI (percutaneous coronary intervention) in people with Patency of the Radial Artery, run by NAUSICA Investigators at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan, India, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Radial Artery Occlusion (time frame: within 2 days after TRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.