Radial Access for Abdominopelvic Vascular Intervention

Zhongda Hospital1,143 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,143

Conditions

Vascular Access Device Complications

Interventions

abdominopelvic vascular intervention through the radial artery accessPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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; 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;

Time frame: 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.

Time frame: up to 1 day after surgery

Complications related to radial approach

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;

Time frame: up to 1 month after surgery

Secondary Outcomes

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;

Time frame: up to 1 day after surgery

Central Contacts

Hai-Dong Zhu, MD

CONTACT

+862583262224 zhuhaidong9509@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.