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This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow.
All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VasQ device implantation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VasQ | Device | An external support device for AV fistula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency of AVF | Proportion of patients with freedom from intervention since device placement | 6 months post AVF creation |
| Number of Participants With Access Related Safety Events | Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma | Device implantation to 6 months post AVF creation |
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Inclusion Criteria:
Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
Male and female participants.
Age 18-80 years.
Patients willing and able to attend follow up visits over a period of 24 months.
Exclusion Criteria:
Patients with the planned index procedure being a revision surgery of an existing fistula.
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.
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.
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.)
Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
Patients with central venous stenosis or obstruction on the side of surgery.
Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
Known coagulation disorder.
Congestive heart failure NYHA class ≥ 3.
Prior steal on the side of surgery.
Known allergy to nitinol.
Life expectancy less than 30 months.
Patients expecting to undergo kidney transplant within 6 months of enrollment.
Women of child bearing age without documented current negative pregnancy test.
Inability to give consent and/or comply with the study follow up schedule.
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| Name | Affiliation | Role |
|---|---|---|
| Noam Zilberman | Laminate Medical Technologies Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| Arizona Kidney Disease & Hypertension Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27079670 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2021 |
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| Phoenix |
| Arizona |
| 85012 |
| United States |
| Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Lutheran Medical Group/Indiana Ohio Heart | Fort Wayne | Indiana | 46804 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Charlotte PA | Charlotte | North Carolina | 28207 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Ohio State University Wexner Meidcal Center | Columbus | Ohio | 43210 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Cardiothoracic and Vascular Surgeons, P.A. | Austin | Texas | 78756 | United States |
| Methodist DeBakey Heart and Vascular Center,The Methodist Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Patency of AVF | Proportion of patients with freedom from intervention since device placement | Posted | Count of Participants | Participants | 6 months post AVF creation |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants With Access Related Safety Events | Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma | Posted | Count of Participants | Participants | Device implantation to 6 months post AVF creation |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VasQ Device Implantation | All patients in the study VasQ: An external support device for AV fistula | 21 | 144 | 9 | 144 | 0 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Kidney transplant | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Orit Yardeb, VP Clinical and Regulatory Affairs | Laminate Medical Technologies | +97236344246 | orit@laminatemedical.com |
| Apr 26, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D007676 | Kidney Failure, Chronic |
| D000783 | Aneurysm |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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