Early Feasibility of the Velocity™ Percutaneous pAVF System (VENOS-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05757726|
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula||Device: Velocity pAVF system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System|
|Actual Study Start Date :||February 14, 2023|
|Estimated Primary Completion Date :||June 15, 2023|
|Estimated Study Completion Date :||May 1, 2024|
|Experimental: Interventional Arm||
Device: Velocity pAVF system
A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.
- Procedural Success [ Time Frame: Immediate ]Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis
- Serious Adverse Device Events [ Time Frame: 6 weeks ]Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.
- Major Reintervention [ Time Frame: 6 weeks ]Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757726
|Contact: Laura Minarsch||408 242 firstname.lastname@example.org|
|Contact: Erik van der Burgemail@example.com|
|Contact: Santiago Gallo, MD|
|Principal Investigator:||Adrian Ebner, MD||Sanatorio Italiano|