Vascular Access Device ComplicationsNCT05956860
Radial Access for Abdominopelvic Vascular Intervention
An observational study of Vascular Access Device Complications, run by Zhongda Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of R.A.V.I.(radial access for abdominopelvic vascular intervention), and evaluate the feasibility and safety of repeated radial artery intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Device Complications
- What is being tested?
- abdominopelvic vascular intervention through the radial artery access
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,143 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2023to 30 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the pathological changes and needs of the subjects (any abdominal and pelvic arterial intervention that can be performed through the radial artery access, including but not limited to: 1. hepatic intervention, such as transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), etc.; 2. Other visceral intervention, such as spleen, kidney, mesentery, etc.; 3. Pelvic intervention, such as uterine artery embolism, prostatic artery embolism, etc.; 4. Others, such as preoperative embolization of bone tumors (lumbar, sacral vertebra), etc.
Who may be able to join
- Age ≥18 years old, gender is not limited;
- Patients who need abdominopelvic transarterial interventions
- Preoperative ultrasound assessment of radial artery diameter ≥2mm;
- Those with good radial pulse and normal Barbeau test (non-D wave);
- There was no infection, redness swelling or ulceration near the puncture site;
- Patients and(or) family members agreed to participate in the clinical study and signed informed consent
Who cannot join
- Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
- Absence or occlusion of the radial artery pulse;
- Need large sheath (≥6Fr);
- Previous history of stroke;
- Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
- Previous history of interventional procedure through radial artery approach (re-intervention of enrolled patients is not included);
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- The investigator believes that the aortic calcification is severe. and the risk of plaque detachment is existed;
- Patients and(or) family members do not agree to join the clinical trials and sign the informed consent ;
- According to the investigator's judgment, there are other conditions that are not suitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Gaojun Teng, MD
About this study
Official title: Evaluating the Safety and Efficacy of Radial Access for Abdominopelvic Vascular Intervention: a Prospective, Multicenter Study
To evaluate the safety and efficacy of R.A.V.I.(radial access for abdominopelvic vascular intervention), and evaluate the feasibility and safety of repeated radial artery intervention
Read the detailed description
This is a prospective, multicenter clinical study with 1143 patients scheduled to enroll based on data from 10 hospitals for any abdominopelvic vascular intervention that can be performed via a radial approach。 The investigators conducted abdominopelvic vascular interventional therapy via radial artery approach according to the lesions and conditions of the subjects.
All subjects underwent Barbeau tests before surgery to examine the flow traffic of the radial and ulnar arteries, and to measure the diameter of the radial artery (inner diameter) by Doppler ultrasound to evaluate its compatibility with the outer diameter of the vascular sheath.
All enrolled subjects were followed up within 24 hours and 1 month after unsheathing to observe the clinical outcome of patients.
- Conditions
- Vascular Access Device Complications
- Being tested
- abdominopelvic vascular intervention through the radial artery access
- Keywords
- Radial access, abdominopelvic vascular intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominopelvic vascular intervention through the radial artery accessProcedure or surgery
According to the pathological changes and needs of the subjects (any abdominal and pelvic arterial intervention that can be performed through the radial artery access, including but not limited to:
- hepatic intervention, such as transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), etc.;
- Other visceral intervention, such as spleen, kidney, mesentery, etc.;
- Pelvic intervention, such as uterine artery embolism, prostatic artery embolism, etc.;
- Others, such as preoperative embolization of bone tumors (lumbar, sacral vertebra), etc.
| Study group | Role | What they receive |
|---|---|---|
| radial access for abdominopelvic vascular intervention | abdominopelvic vascular intervention through the radial artery access Receives: Procedure: abdominopelvic vascular intervention through the radial artery access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate: radial artery puncture success rate and procedure success rate
1)The definition of successful puncture: the radial artery sheath is inserted into the radial artery;
- The definition of successful puncture: the radial artery sheath was inserted into the radial artery;
- The definition of successful procedure: the catheter was inserted into the target blood vessel via the radial artery, the target procedures was completed, and no crossover to other approach;
Measured: up to 1 day after surgery
Puncture success rate and procedure success rate of repeated radial artery intervention
Repeat radial artery intervention: two or more procedures in the same patient with ipsilateral radial artery intervention.
Measured: up to 1 day after surgery
Complications related to radial approach
- Minor complications: such as radial artery pulse weakening or disappearance without evidence of distal ischemia, local hematoma* formation or bleeding without blood transfusion or surgical intervention, radial artery spasm*, etc.
- Asymptomatic or mild symptoms, no treatment, no sequelae; ii. Minor treatment, including overnight observation only, without sequelae;
- Major complication: Such as the need for blood transfusion, limb ischemia, pseudoaneurysm*, any complications requiring surgical intervention, etc.
- Short-term hospitalization (<48 hours) ii. Unexpected level of care escalation, prolonged hospital stay(>48 hours) iii. Permanent damage; iv. Die;
Measured: up to 1 month after surgery
Secondary outcomes (1)
Radial artery puncture and sheath insertion time;
The time from the first attempt to puncture with a puncture needle to the successful insertion of the vascular sheath into the radial artery;
Measured: up to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start7 Aug 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access Device ComplicationsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956860
- Sponsor's protocol ID
- RAVI-202301
- Status last verified
- Dec 2023
- First submitted
- 11 Jul 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Radial Access for Abdominopelvic Vascular Intervention: a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT05956860
- Acronym / sponsor ID
- RAVI-202301
- Conditions
- Vascular Access Device Complications
- Keywords
- Radial access, abdominopelvic vascular intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,143 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Jul 2023 (actual)
- 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.
To evaluate the safety and efficacy of R.A.V.I.(radial access for abdominopelvic vascular intervention), and evaluate the feasibility and safety of repeated radial artery intervention
Detailed description
This is a prospective, multicenter clinical study with 1143 patients scheduled to enroll based on data from 10 hospitals for any abdominopelvic vascular intervention that can be performed via a radial approach。 The investigators conducted abdominopelvic vascular interventional therapy via radial artery approach according to the lesions and conditions of the subjects.
All subjects underwent Barbeau tests before surgery to examine the flow traffic of the radial and ulnar arteries, and to measure the diameter of the radial artery (inner diameter) by Doppler ultrasound to evaluate its compatibility with the outer diameter of the vascular sheath.
All enrolled subjects were followed up within 24 hours and 1 month after unsheathing to observe the clinical outcome of patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radial access for abdominopelvic vascular intervention | – | Procedure: abdominopelvic vascular intervention through the radial artery accessabdominopelvic vascular intervention through the radial artery access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the pathological changes and needs of the subjects (any abdominal and pelvic arterial intervention that can be performed through the radial artery access, including but not limited to: 1. hepatic intervention, such as transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), etc.; 2. Other visceral intervention, such as spleen, kidney, mesentery, etc.; 3. Pelvic intervention, such as uterine artery embolism, prostatic artery embolism, etc.; 4. Others, such as preoperative embolization of bone tumors (lumbar, sacral vertebra), etc.
Key inclusion criteria (6 listed)
- Age ≥18 years old, gender is not limited;
- Patients who need abdominopelvic transarterial interventions
- Preoperative ultrasound assessment of radial artery diameter ≥2mm;
- Those with good radial pulse and normal Barbeau test (non-D wave);
- There was no infection, redness swelling or ulceration near the puncture site;
Key exclusion criteria (9 listed)
- Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
- Absence or occlusion of the radial artery pulse;
- Need large sheath (≥6Fr);
- Previous history of stroke;
- Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
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 |
|---|---|---|
| abdominopelvic vascular intervention through the radial artery accessAccording to the pathological changes and needs of the subjects (any abdominal and pelvic arterial intervention that can be performed through the radial artery access, including but not limited to: 1. hepatic intervention, such as transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), etc.; 2. Other visceral intervention, such as spleen, kidney, mesentery, etc.; 3. Pelvic intervention, such as uterine artery embolism, prostatic artery embolism, etc.; 4. Others, such as preoperative embolization of bone tumors (lumbar, sacral vertebra), etc. | Procedure or surgery | radial access for abdominopelvic vascular intervention |
Primary outcome
Technical success rate: radial artery puncture success rate and procedure success rate
Time frame: up to 1 day after surgery
1)The definition of successful puncture: the radial artery sheath is inserted into the radial artery; 1. The definition of successful puncture: the radial artery sheath was inserted into the radial artery; 2. The definition of successful procedure: the catheter was inserted into the target blood vessel via the radial artery, the target procedures was completed, and no crossover to other approach;
Puncture success rate and procedure success rate of repeated radial artery intervention
Time frame: up to 1 day after surgery
Repeat radial artery intervention: two or more procedures in the same patient with ipsilateral radial artery intervention.
Complications related to radial approach
Time frame: up to 1 month after surgery
a) Minor complications: such as radial artery pulse weakening or disappearance without evidence of distal ischemia, local hematoma* formation or bleeding without blood transfusion or surgical intervention, radial artery spasm*, etc. i. Asymptomatic or mild symptoms, no treatment, no sequelae; ii. Minor treatment, including overnight observation only, without sequelae; b) Major complication: Such as the need for blood transfusion, limb ischemia, pseudoaneurysm*, any complications requiring surgical intervention, etc. i. Short-term hospitalization (<48 hours) ii. Unexpected level of care escalation, prolonged hospital stay(>48 hours) iii. Permanent damage; iv. Die;
1 secondary outcome
Radial artery puncture and sheath insertion time;
Time frame: up to 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Device Complications, run by Zhongda Hospital 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 6 inclusion and 9 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 21 Dec 2023. 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 Hai-Dong Zhu, MD (+862583262224, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate: radial artery puncture success rate and procedure success rate (time frame: up to 1 day after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2023.