Radial Access for Abdominopelvic Vascular Intervention

NCT ID: NCT05956860

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2025-12-30

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.

Conditions

Vascular Access Device Complications

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

radial access for abdominopelvic vascular intervention

abdominopelvic vascular intervention through the radial artery access

abdominopelvic vascular intervention through the radial artery access

Intervention Type: PROCEDURE

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.

Interventions

abdominopelvic vascular intervention through the radial artery access

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao-jun Teng

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gao-Jun Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hai-Dong Zhu, MD

Role: CONTACT

zhuhaidong9509@163.com

+862583262224

Facility Contacts

Gaojun Teng, MD

Role: primary

Other Identifiers

RAVI-202301

Identifier Type: -

Identifier Source: org_study_id