Radial Access for Abdominopelvic Vascular Intervention

NCT05956860 | Unknown

• 1 other identifier: RAVI-202301
• Study Type: observational
• Target: 1,143
• Locations: 1 country
• Sites: 1

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

Conditions

Vascular Access Device Complications

Keywords

Radial access, abdominopelvic vascular intervention

Outcome Measures

Primary Outcomes (3)

• 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; 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;

  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 Outcomes (1)

• Radial artery puncture and sheath insertion time;

  up to 1 day after surgery

Other Outcomes (5)

• The time of successfully intubation of angiographic catheter;

  up to 1 day after surgery

• Access site crossover rate

  up to 1 day after surgery

• Hemostasis time at the puncture site;

  up to 1 day after surgery

Study Arms (1)

radial access for abdominopelvic vascular intervention

abdominopelvic vascular intervention through the radial artery access

Procedure: abdominopelvic vascular intervention through the radial artery access

Interventions

abdominopelvic vascular intervention through the radial artery access 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.

radial access for abdominopelvic vascular intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years old, gender is not limited;
• Patients who need abdominopelvic transarterial interventions
• Preoperative ultrasound assessment of radial artery diameter ≥2mm;
• Those with good radial pulse and normal Barbeau test (non-D wave);
• There was no infection, redness swelling or ulceration near the puncture site;
• Patients and(or) family members agreed to participate in the clinical study and signed informed consent

You may not qualify if:

• Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
• Absence or occlusion of the radial artery pulse;
• Need large sheath (≥6Fr);
• Previous history of stroke;
• Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
• Previous history of interventional procedure through radial artery approach (re-intervention of enrolled patients is not included);
• The investigator believes that the aortic calcification is severe. and the risk of plaque detachment is existed;
• Patients and(or) family members do not agree to join the clinical trials and sign the informed consent ;
• According to the investigator's judgment, there are other conditions that are not suitable for participating in this clinical study.

Sponsors & Collaborators

• Zhongda Hospital: lead
• Terumo Medical Corporation: collaborator

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu, MD

CONTACT

+862583262224; zhuhaidong9509@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 21, 2023
• Study Start: August 7, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

CN (1)