Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
144 participants
INTERVENTIONAL
2017-11-29
2022-04-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
NCT02112669
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
NCT06516653
Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis
NCT01868984
Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
NCT02753998
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
NCT04282161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VasQ device implantation
Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints.
Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
VasQ
An external support device for AV fistula
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VasQ
An external support device for AV fistula
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
2. Male and female participants.
3. Age 18-80 years.
4. Patients willing and able to attend follow up visits over a period of 24 months.
Exclusion Criteria
2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
6. Patients with central venous stenosis or obstruction on the side of surgery.
7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
8. Known coagulation disorder.
9. Congestive heart failure NYHA class ≥ 3.
10. Prior steal on the side of surgery.
11. Known allergy to nitinol.
12. Life expectancy less than 30 months.
13. Patients expecting to undergo kidney transplant within 6 months of enrollment.
14. Women of child bearing age without documented current negative pregnancy test.
15. Inability to give consent and/or comply with the study follow up schedule.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Laminate Medical Technologies
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Noam Zilberman
Role: STUDY_DIRECTOR
Laminate Medical Technologies Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grandview Medical Center
Birmingham, Alabama, United States
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, United States
Saint Francis Medical Center
Peoria, Illinois, United States
Lutheran Medical Group/Indiana Ohio Heart
Fort Wayne, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Albany Medical College
Albany, New York, United States
Montefiore Medical Center
New York, New York, United States
Charlotte PA
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Wexner Meidcal Center
Columbus, Ohio, United States
Greenville Health System
Greenville, South Carolina, United States
Cardiothoracic and Vascular Surgeons, P.A.
Austin, Texas, United States
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CD0121
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.