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| Name | Class |
|---|---|
| Terumo Medical Corporation | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radial access for abdominopelvic vascular intervention | abdominopelvic vascular intervention through the radial artery access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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;
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Dong Zhu, MD | Contact | +862583262224 | zhuhaidong9509@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | China |
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|
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 |