Radial Access for Abdominopelvic Vascular Intervention

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

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

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Device Complications
• Intervention / Treatment: Procedure: abdominopelvic vascular intervention through the radial artery access

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 Type: Observational
• Enrollment (Estimated): 1143

Contacts and Locations

• Study Contact: Name: Hai-Dong Zhu, MD; Phone Number: +862583262224; Email: zhuhaidong9509@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital Southeast University
      • Contact: Gaojun Teng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

radial access for abdominopelvic vascular intervention; abdominopelvic vascular intervention through the radial artery access

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hemostasis time at the puncture site;	the time from pulling put the sheath to complete hemostasis.	up to 1 day after surgery
Evaluation of post-procedure comfort	Evaluation of patient comfort using the Post-catheterization Questionaire (1 day after procedure).	up to 1 month after surgery
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

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Collaborators: Terumo Medical Corporation
• Investigators: Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radial access, abdominopelvic vascular intervention
• Other Study ID Numbers: RAVI-202301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No