CONNECT-AV: Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Study Details
Study Description
Brief Summary
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EndoAVF
|
Device: EndoAVF Creation
Subjects will have an endoAVF created using the WavelinQ EndoAVF System
|
Outcome Measures
Primary Outcome Measures
- Functional Cannulation Success [6-months post index procedure]
The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period
- Primary Patency [6-months post index procedure]
Subjects maintaining primary patency of the endoAVF
- Device- and procedure-related serious adverse events (SAE) [30-days post index procedure]
Freedom from device-related or procedure-related SAEs
Secondary Outcome Measures
- Physiological Maturation [2-weeks, 6-weeks, 6-months, and 24-months post index procedure]
Defined by duplex ultrasound flow in the brachial artery of at least 500ml/min and outflow vein diameter ≥ 4mm
- Functional Maturation [6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
Successful prescribed dialysis with 2-needle cannulation of the endoAVF for three continuous weeks
- Procedure Success [Index procedure]
Successful endoAVF creation
- Cannulation Success [6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
Successful 2-needle endoAVF cannulation
- Primary Patency [6-weeks, 3-, 12-, 18-, and 24-months post index procedure]
Subjects maintaining primary patency of the endoAVF
- Assisted Primary Patency [6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
Subjects maintaining assisted primary patency of the endoAVF
- Secondary Patency [6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
Subjects maintaining secondary patency of the endoAVF
- Functional Patency [through 24-months]
Interval of time from endoAVF cannulation success to involuntary access abandonment
- Functional Cannulation Success [3-, 12-, 18-, and 24-months post index procedure]
The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period
- CVC Exposure/Use [6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
- Procedural Adjunctive Procedures [Index Procedure]
Adjunctive procedures performed at the time of the index procedure
- Post Procedural Secondary Procedures [2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
Number of secondary procedures conducted after the index procedure, broken down to identify interventions and second stage procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
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Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
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Subject must be willing to comply with the protocol requirements, including clinical follow-up.
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Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis.
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Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
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Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
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Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
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At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.
Exclusion Criteria:
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The subject is in a hypercoagulable state.
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The subject has known bleeding diathesis.
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The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
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Known history of active intravenous drug abuse.
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"Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
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The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
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The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
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Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
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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.
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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.
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The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
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Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
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Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
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Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
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Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radiology and Imaging Specialists | Lakeland | Florida | United States | 33801 |
| 2 | Vascular and Interventional Specialists | Miami | Florida | United States | 33156 |
| 3 | SSM St. Mary's | Saint Louis | Missouri | United States | 63117 |
| 4 | Albany Medical Center | Albany | New York | United States | 12208 |
| 5 | Butler Memorial Hospital | Butler | Pennsylvania | United States | 16001 |
| 6 | Baylor Scott & White | Dallas | Texas | United States | 75226 |
| 7 | Houston Methodist | Houston | Texas | United States | 77030 |
| 8 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- C. R. Bard
Investigators
- Principal Investigator: Eric Peden, MD, The Methodist Hospital Research Institute
- Principal Investigator: Paul Kreienberg, MD, Albany Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPV-18-002