Radial Access for Abdominopelvic Vascular Intervention

Vascular Access Device Complications Clinical Trial

Official title:

Evaluating the Safety and Efficacy of Radial Access for Abdominopelvic Vascular Intervention: a Prospective, Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956860
• Other study ID #: RAVI-202301
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Zhongda Hospital
• Contact: Hai-Dong Zhu, MD
• Phone: +862583262224
• Email: zhuhaidong9509[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1143
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Access Device Complications

Intervention

Procedure:
• 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: hepatic intervention, such as transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), etc.; Other visceral intervention, such as spleen, kidney, mesentery, etc.; Pelvic intervention, such as uterine artery embolism, prostatic artery embolism, etc.; Others, such as preoperative embolization of bone tumors (lumbar, sacral vertebra), etc.

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Zhongda Hospital	Terumo Medical Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The time of successfully intubation of angiographic catheter;	The time from the angiographic catheter entering the vascular sheath to the first-level branch of the aorta, and the time from the first-level branch of the aorta to the target branch.	up to 1 day after surgery
Other	Access site crossover rate	The rate of crossing over to the contralateral side through the femoral artery puncture route.	up to 1 day after surgery
Other	Hemostasis time at the puncture site;	the time from pulling put the sheath to complete hemostasis.	up to 1 day after surgery
Other	Evaluation of post-procedure comfort	Evaluation of patient comfort using the Post-catheterization Questionaire (1 day after procedure).	up to 1 month after surgery
Other	Evaluation of post-procedure quality of life	Evaluation of post-procedure quality of life with SF-8 (30 days after procedure).	up to 1 month after surgery
Primary	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; The definition of successful puncture: the radial artery sheath was inserted into the radial artery; 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;	up to 1 day after surgery
Primary	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.	up to 1 day after surgery
Primary	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;	up to 1 month after surgery
Secondary	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;	up to 1 day after surgery