A prospective, multi-center, randomized, concurrently-controlled clinical study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the treatment of stenosis in the venous outflow of AV fistula access circuits (AVeNEW)

Not Applicable

• Conditions: Stenoses in the upper extremity venous outflow of patients dialyzing with an arterio-venous (AV) access fistula.

• Registration Number: DRKS00010189
• Lead Sponsor: Bard Peripheral Vascular, Inc.

Brief Summary

The AVeNEW study results provide scientific evidence that the COVERA™Vascular Covered Stent and Delivery System is safe and effective for the treatment of stenotic lesions in the venous outflow of hemodialysis subjects dialyzing with an AV fistula.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-07
• Study Completion: 2020-10-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Clinical Inclusion Criteria
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female = 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up.
4. Subject must have an upper extremity AV fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure.

Angiographic Inclusion Criteria
5. Subject must have angiographic evidence of a stenosis = 50% (by visual estimation) located in the venous outflow of the AV access circuit and present with clinical or hemodynamic evidence of AV fistula dysfunction.
6. The target lesion must be = 9 cm in length. Note: multiple stenoses may exist within the target lesion.
7. The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0 mm.

Exclusion Criteria

Clinical Exclusion Criteria
1. The subject is dialyzing with an AV graft.
2. The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
3. The hemodialysis access is located in the lower extremity.
4. The subject has an infected AV fistula or uncontrolled systemic infection.
5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
7. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
8. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
9. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Angiographic Exclusion Criteria
10. Additional stenotic lesions (= 50%) in the venous outflow that are > 3cm from the edge of the target lesion and are not successfully treated (defined as < 30% residual stenosis) prior to treating the target lesion.
11. An aneurysm or pseudoaneurysm is present within the target lesion.
12. The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint.
13. The target lesion is located within a stent.
14. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be deployed at or across the segment of fistula utilized for dialysis needle puncture (i.e., cannulation zone”).
15. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet.
16. There is incomplete expansion of an appropriately sized angioplasty balloon to its expected profile, in the operator’s judgment, during primary angioplasty at the target lesion prior to randomization.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Target Lesion Primary Patency (TLPP) through 6 months, with Hypothesis Testing;<br>Hypothesis: The patency rate in subjects treated with the COVERA™ Vascular Covered Stent is greater than that in subjects treated with PTA alone.<br>Patency is not determined by routine diagnostics (Ultrasound, angiogpraphy). Patency of the target lesion ends when clinically relevant symptoms occur and a re-intervention is required.<br><br>• Safety through 30 days, with Hypothesis Testing;<br>Hypothesis: The Adverse Event rate in subjects treated with the COVERA™ Vascular Covered Stent is non-inferior to that in subjects treated with PTA alone.