InterventionNCT01979627
Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
A study testing transulnar approach interventional procedure and transradial approach interventional procedure in people with Intervention and Transulnar, run by Fu Xianghua at 1 site in China.
Trial summary
The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intervention, Transulnar, Transradial
- What is being tested?
- transulnar approach interventional procedure and transradial approach interventional procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coronary artery disease
- Needed to perform coronary angiography or angioplasty
Who cannot join
- Arterial circulatory disease in an upper limb
- History of deformity
- Forearm trauma
- Forearm amputated
- Hemodialysis
- Symptomatic peripheral artery disease
Show all 10Show fewer
- Raynaud's syndrome
- Hemorrhagic disease
- Cardiogenic shock
- Others who were unwilling to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second hospital of Hebei medical university
Shijiazhuang, Hebei, 050000
Xianghua FU, doctor, +8631166003830, Fuxh999@163.com
Xianghua FU, doctor
About this study
The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. However, the transradial approach does not seem suitable for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is one of the two terminal branches of the brachial artery is usually larger than radial artery and it may be as a potential approach for cardiac catheterization. Recently, some reports have demonstrated that the transulnar approach may be both feasible and safe for coronary angiography and angioplasty in selective patients.we performed this study to evaluate the safety and feasibility of transulnar approach coronary catheterization in real world non-selective patients.
- Conditions
- Intervention, Transulnar, Transradial
- Being tested
- transulnar approach interventional procedure, transradial approach interventional procedure
- Keywords
- transulnar approach, transradial approach, angiography, angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transulnar approach interventional procedureProcedure or surgery
transradial approach interventional procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transulnar approach group | Experimental | Patients in transulnar group received interventional procedure through ulnar artery Receives: Procedure: transulnar approach interventional procedure |
| transradial approach group | Other | patients in transradial group received interventional procedure through radial artery Receives: Procedure: transradial approach interventional procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery cannulation
vascular events including arterial occlusion through ulnar/radial artery approach
Measured: 1-12 month
Secondary outcomes (2)
Interventional procedure characteristic
The secondary end points included the crossover rate, spasm, total time for the procedure
Measured: during procedure
The access-site related complications
The access-site related complications were defined as the occurrence of hematoma, artery stenosis, arteriovenous fistula, pseudoaneurysm, and nerve injury
Measured: 1-12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InterventionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xianghua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fu Xianghua, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979627
- Sponsor's protocol ID
- fuxhtransulnar
- Status last verified
- Jan 2017
- First submitted
- 24 Oct 2013
- Last updated
- 11 Jan 2017
- Results posted
- No
Publications
Chen J, Huai J, Lin L, Li B, Zhu Y, Yang H. Low-dose aspirin in the prevention of pre-eclampsia in China: postpartum hemorrhage in subgroups of women according to their characteristics and potential bleeding risk. Chin Med J (Engl). 2023 Mar 5;136(5):550-555. doi: 10.1097/CM9.0000000000002545.
PubMed 36914957Liu L, Xu XT, Yu Y, Sun Q, Yang Y, Qiu HB. Neural control of pressure support ventilation improved patient-ventilator synchrony in patients with different respiratory system mechanical properties: a prospective, crossover trial. Chin Med J (Engl). 2021 Jan 19;134(3):281-291. doi: 10.1097/CM9.0000000000001357.
PubMed 33470654Bi X, Wang Q, Liu D, Gan Q, Liu L. Is the Complication Rate of Ulnar and Radial Approaches for Coronary Artery Intervention the Same? Angiology. 2017 Nov;68(10):919-925. doi: 10.1177/0003319717703226. Epub 2017 Apr 7.
PubMed 28387125Bi XL, Fu XH, Gu XS, Wang YB, Li W, Wei LY, Fan YM, Bai SR. Influence of Puncture Site on Radial Artery Occlusion After Transradial Coronary Intervention. Chin Med J (Engl). 2016 Apr 20;129(8):898-902. doi: 10.4103/0366-6999.179795.
PubMed 27064032
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
- ClinicalTrials.gov ID
- NCT01979627
- Acronym / sponsor ID
- fuxhtransulnar
- Conditions
- Intervention, Transulnar, Transradial
- Keywords
- transulnar approach, transradial approach, angiography, angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fu XianghuaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. However, the transradial approach does not seem suitable for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is one of the two terminal branches of the brachial artery is usually larger than radial artery and it may be as a potential approach for cardiac catheterization. Recently, some reports have demonstrated that the transulnar approach may be both feasible and safe for coronary angiography and angioplasty in selective patients.we performed this study to evaluate the safety and feasibility of transulnar approach coronary catheterization in real world non-selective patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transulnar approach group | Experimental | Procedure: transulnar approach interventional procedurePatients in transulnar group received interventional procedure through ulnar artery |
| transradial approach group | Other | Procedure: transradial approach interventional procedurepatients in transradial group received interventional procedure through radial artery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of coronary artery disease
- Needed to perform coronary angiography or angioplasty
Key exclusion criteria (10 listed)
- Arterial circulatory disease in an upper limb
- History of deformity
- Forearm trauma
- Forearm amputated
- Hemodialysis
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 |
|---|---|---|
| transulnar approach interventional procedure | Procedure or surgery | transulnar approach group |
| transradial approach interventional procedure | Procedure or surgery | transradial approach group |
Primary outcome
Coronary artery cannulation
Time frame: 1-12 month
vascular events including arterial occlusion through ulnar/radial artery approach
2 secondary outcomes
Interventional procedure characteristic
Time frame: during procedure
The access-site related complications
Time frame: 1-12 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 36914957Chen J, Huai J, Lin L, Li B, Zhu Y, Yang H. Low-dose aspirin in the prevention of pre-eclampsia in China: postpartum hemorrhage in subgroups of women according to their characteristics and potential bleeding risk. Chin Med J (Engl). 2023 Mar 5;136(5):550-555. doi: 10.1097/CM9.0000000000002545.
- Derived from this study: PubMed 33470654Liu L, Xu XT, Yu Y, Sun Q, Yang Y, Qiu HB. Neural control of pressure support ventilation improved patient-ventilator synchrony in patients with different respiratory system mechanical properties: a prospective, crossover trial. Chin Med J (Engl). 2021 Jan 19;134(3):281-291. doi: 10.1097/CM9.0000000000001357.
- Derived from this study: PubMed 28387125Bi X, Wang Q, Liu D, Gan Q, Liu L. Is the Complication Rate of Ulnar and Radial Approaches for Coronary Artery Intervention the Same? Angiology. 2017 Nov;68(10):919-925. doi: 10.1177/0003319717703226. Epub 2017 Apr 7.
- Derived from this study: PubMed 27064032Bi XL, Fu XH, Gu XS, Wang YB, Li W, Wei LY, Fan YM, Bai SR. Influence of Puncture Site on Radial Artery Occlusion After Transradial Coronary Intervention. Chin Med J (Engl). 2016 Apr 20;129(8):898-902. doi: 10.4103/0366-6999.179795.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transulnar approach interventional procedure and transradial approach interventional procedure in people with Intervention and Transulnar, run by Fu Xianghua at 1 site in China.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianghua FU (+8631166003803, fuxh999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery cannulation (time frame: 1-12 month). 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 NCT01979627, which also lists 4 linked publications.
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 11 Jan 2017.