Using radial access for vascular interventions in the abdomen and pelvis

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

This study tests whether using the wrist for vascular procedures in the abdomen and pelvis is safe and effective for patients.

Quick facts

• Study type: Observational
• Enrollment: 1143 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05956860 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of using radial access for abdominopelvic vascular interventions in a multicenter setting involving 1143 patients. Participants will undergo preoperative assessments, including Barbeau tests and Doppler ultrasound, to ensure compatibility for the procedure. The study will monitor clinical outcomes within 24 hours and one month post-intervention to assess the feasibility and safety of repeated radial artery interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require abdominopelvic transarterial interventions and meet specific preoperative criteria.

Not a fit: Patients with severe allergies to contrast media, occluded radial arteries, or those requiring larger sheaths may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective vascular interventions for patients requiring abdominopelvic procedures.

How similar studies have performed: While the use of radial access is gaining traction, this specific application for abdominopelvic interventions is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Gao-Jun Teng, MD — Zhongda Hospital
• Study coordinator: Hai-Dong Zhu, MD

Conditions Vascular Access Device Complications; Radial access, abdominopelvic vascular intervention