Radial Access for Abdominopelvic Vascular Intervention

Southeast University

Status: Enrolling

Conditions: Vascular Access Device Complications

Treatments: Procedure: abdominopelvic vascular intervention through the radial artery access

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05956860

RAVI-202301

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,143 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,143 participants in 1 patient group

radial access for abdominopelvic vascular intervention

Description:

abdominopelvic vascular intervention through the radial artery access

Treatment:

Procedure: abdominopelvic vascular intervention through the radial artery access