Clinical Evidence 

R2V™ - Radial to Visceral

Key Clinical Evidence

• Prospective, Multi-Center, Registry Study of Radial Access Embolization Procedures: 30 Day Outcomes (RAVI Registry- NCT04272216)¹
• Midterm Recanalization after Arterial Embolization Using Hydrogel-Coated Coils versus Fibered Coils in an Animal Model2
• Usefulness of Hydrogel-Coated Coils in Embolization of Pulmonary Arteriovenous Malformations3
• Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils in Peripheral Arterial Applications: A Prospective, Multicenter, Randomized Trial4

Prospective, Multi-Center, Registry Study of Radial Access Embolization Procedures¹

Overview

A prospective registry on 30-day outcomes with 12 month follow up was conducted to increase the data available on radial access in visceral interventions (RAVI) and to show that radial access is safe and feasible for a wide range of embolization procedures.

Study Design

• Non-randomized study, conducted by Interventional Radiologists, sponsored by Terumo Interventional Systems. 
• Left radial access used for embolotherapy procedures to treat uterine fibroids, benign prostatic hyperplasia, liver tumors, and other hypervascular tumors. 
•Eligibility criteria included 18 yrs. of age, able to provide informed consent and willing to participate in a 30 day and 12 month clinical follow-up. 
• Subject eligibility for radial access (RA) was assessed according to the Barbeau test (positive)2, pre-procedure ultrasound to check patency and whether the radial artery had > 1.6 mm in the antero-posterior diameter. 
• Subjects were enrolled at six participating institutions:

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Midterm Recanalization after Arterial Embolization Using Hydrogel-Coated Coils versus Fibered Coils in an Animal Model²

Overview

To compare angiographic and pathologic effects (ie, occlusion, recanalization) after embolization with Hydrogel-coated coils and fibered coils in the renal and internal iliac arteries after 7 days and 1 and 4 months in an animal model. 

Study Design

• 12 sheep had 1 iliac and 1 renal artery randomly embolized with hydrogel-coated coils or fibered coils. 
• Hydrogel-coated coils (Azur™ HydroCoil™ System) were used in 12 arteries and fibered coils (Interlock and Nester) were used in 12 arteries. 
• Renal arteries were embolized with detachable 0.018 inch coils and iliac arteries were embolized with pushable 0.035 inch coils. 
• Control angiography was performed at 7 days, 1 month and 4 months to assess recanalization.

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Usefulness of Hydrogel-Coated Coils in Embolization of Pulmonary Arteriovenous Malformations³

Overview

To evaluate the usefulness of hydrogel-coated coils for preventing recanalization after coil embolization of pulmonary arteriovenous malformations (PAVMs).

Study Design

• Retrospective analysis of 37 consecutive patients with 57 previously untreated PAVMs between Jan 2013 and Jun 2017. 
• Mean age of patients was 49 years (range 9-83 years). 
• Median size of the feeding artery was 3.7mm (range 1.5-6.1mm). 
• Median size of the venous sac was 9.3mm (range 2.6-36.6mm). 
• For all PAVMs, embolization was performed using hydrogel-coated coils with or without other coils.  
• Recanalization was evaluated with time-resolved magnetic resonance angiography and/or pulmonary angiography (TR-MRA).

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Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils in Peripheral Arterial Applications: A Prospective, Multicenter, Randomized Trial⁴

Overview

To evaluate the safety and effectiveness of hydrogel-coated coils for vessel occlusion in the body trunk.

Study Design

• A Prospective, Multicenter, Randomized Trial. 
• A total of 77 patients with various peripheral vascular lesions, treatable by embolization with coils, were randomized (hydrogel group, n=38; nonhydrogel group, n=39). 
• In the hydrogel group, embolization of the target vessel was conducted using 0.018 inch hydrogel-coated coils (AZUR 18; Terumo Corporation, Tokyo, Japan) with or without bare platinum coils. 
• The nonhydrogel group received both bare platinum coils and fibered coils without the use of hydrogel-coated coils.

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Reference