Radial Access for Abdominopelvic Vascular Intervention

Recruiting

• Conditions: Vascular Access Device Complications
• Interventions: Procedure: abdominopelvic vascular intervention through the radial artery access

• Registration Number: NCT05956860
• Lead Sponsor: Zhongda Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-21
• Study Start: 2023-08-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1143

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
radial access for abdominopelvic vascular intervention	abdominopelvic vascular intervention through the radial artery access	abdominopelvic vascular intervention through the radial artery access

Primary Outcome Measures

Name	Time	Method
Technical success rate: radial artery puncture success rate and procedure success rate	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	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	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;

Secondary Outcome Measures

Name	Time	Method
Radial artery puncture and sheath insertion time;	up to 1 day after surgery	The time from the first attempt to puncture with a puncture needle to the successful insertion of the vascular sheath into the radial artery;

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China