Clinical trial NCT05956860: Radial Access for Abdominopelvic Vascular Intervention
Official title: Evaluating the Safety and Efficacy of Radial Access for Abdominopelvic Vascular Intervention: a Prospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Access Device Complications
Keywords: Radial access, abdominopelvic vascular intervention
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
Collaborators: name: Terumo Medical Corporation
First posted: 2023-07-21
Enrollment: 1143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Patients who need abdominopelvic transarterial interventions
3. Preoperative ultrasound assessment of radial artery diameter ≥2mm;
4. Those with good radial pulse and normal Barbeau test (non-D wave);
5. There was no infection, redness swelling or ulceration near the puncture site;
6. Patients and(or) family members agreed to participate in the clinical study and signed informed consent

Exclusion Criteria:

1. Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
2. Absence or occlusion of the radial artery pulse;
3. Need large sheath (≥6Fr);
4. Previous history of stroke;
5. Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
6. Previous history of interventional procedure through radial artery approach (re-intervention of enrolled patients is not included);
7. The investigator believes that the aortic calcification is severe. and the risk of plaque detachment is existed;
8. Patients and(or) family members do not agree to join the clinical trials and sign the informed consent ;
9. According to the investigator's judgment, there are other conditions that are not suitable for participating in this clinical study.

Primary outcomes:
measure: Technical success rate: radial artery puncture success rate and procedure success rate
timeFrame: up to 1 day after surgery
measure: Puncture success rate and procedure success rate of repeated radial artery intervention
timeFrame: up to 1 day after surgery
measure: Complications related to radial approach
timeFrame: up to 1 month after surgery
Secondary outcomes:
measure: Radial artery puncture and sheath insertion time;
timeFrame: up to 1 day after surgery
Other outcomes:
measure: The time of successfully intubation of angiographic catheter;
timeFrame: up to 1 day after surgery
measure: Access site crossover rate
timeFrame: up to 1 day after surgery
measure: Hemostasis time at the puncture site;
timeFrame: up to 1 day after surgery
measure: Evaluation of post-procedure comfort
timeFrame: up to 1 month after surgery
measure: Evaluation of post-procedure quality of life
timeFrame: up to 1 month after surgery
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References: