GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface for Constriction, Pathologic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
American Access Care of Bronx, Bronx, NY
Constriction, Pathologic+1 More
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a covered stent graft is better than standard of care for hemodialysis access.

See full description

Eligible Conditions

  • Constriction, Pathologic
  • Hemodialysis Treatment

Treatment Effectiveness

Study Objectives

This trial is evaluating whether GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface will improve 1 primary outcome and 1 secondary outcome in patients with Constriction, Pathologic. Measurement will happen over the course of 1 year.

1 year
Primary patency at 3, 6, and 12 months
Secondary patency at 3, 6, and 12 months

Trial Safety

Trial Design

2 Treatment Groups

Percutaneous Transluminal Angioplasty (PTA) alone
1 of 2
PTA with covered stent
1 of 2
Active Control
Experimental Treatment

This trial requires 140 total participants across 2 different treatment groups

This trial involves 2 different treatments. GORE VIABAHN® Endoprosthesis With Heparin Bioactive Surface is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PTA with covered stent
Device
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Percutaneous Transluminal Angioplasty (PTA) alone
Other
Intervention: Procedure: PTA alone without use of the GORE VIABAHN

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

American Access Care of Bronx - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A patient who receives hemodialysis and has a mature forearm or upper arm access that was created more than two months before enrolling in the study. show original
The patient can expect to stay on hemodialysis for 12 months. show original
The patient or their guardian is willing to give permission after being fully informed. show original
The patient understands the study and is willing and able to comply with follow-up requirements. show original
exclusion criteria The patient has a condition that meets the requirements for an angiography, which is a test that uses X-rays to look at the inside of the blood vessels. show original
The patient is old enough to be considered an adult. show original

Patient Q&A Section

How many people get constriction, pathologic a year in the United States?

"About one in 10,000 North Americans is diagnosed with constriction, pathologic every year. The most common type of constriction is stricture, followed by sphincter insufficiency. There is no gender difference in the occurrence of constriction." - Anonymous Online Contributor

Unverified Answer

What are the signs of constriction, pathologic?

"Signs of constriction include the appearance of skin or subcutaneous swelling. This type of swelling may vary in extent and can range from an erythematous, papular or pustular appearance. There may be bruising or bleeding associated with the swelling or skin. Pathologic constrictions can occur in many parts of the body.\n" - Anonymous Online Contributor

Unverified Answer

Can constriction, pathologic be cured?

"The pathological changes of constrictive urethroplasty can be effectively alleviated in the short term by the use of the proper implant materials and the appropriate surgical technique. In cases in which the pathological changes were not relieved, these patients are more likely to suffer from persistent pain and the need for additional surgical procedures." - Anonymous Online Contributor

Unverified Answer

What are common treatments for constriction, pathologic?

"Although the optimal treatment approach continues to be debated, current guidelines for management of constriction, pathologic suggest that treatment includes reassurance, pain relief, and medications to relieve anxiety, minimize skin breakdown, and induce maturation of the new skin in those with large lesions. However, the best treatment regimen for a particular patient with a specific disease remains unknown." - Anonymous Online Contributor

Unverified Answer

What is constriction, pathologic?

"The pathologic constriction of biliary strictures presents as a challenge to endoscopic management. In an effort to preserve the integrity of the strictures and to avoid the development of a perforation, a dilating sphincterotomy is frequently used. This may involve balloon dilation, electrocautery, argon-beam coagulation, or the use of a stent. Nevertheless, with the development of improved laser technology, a laser-assisted balloon dilation (LAD) may become the first choice to preserve the patency of biliary strictures. In the clinical setting, LAD was associated with increased morbidity and mortality because of the technical complexity of the procedure." - Anonymous Online Contributor

Unverified Answer

What causes constriction, pathologic?

"These disorders have an impact on the smooth muscle in the tunica media of both large and small vessels in the body. The cause of these disorders is multifactorial and includes both genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets constriction, pathologic?

"The mean reported age of onset of constriction, pathologic is 12.5 years old. The number of reported cases of this condition increased exponentially between 1977 and 1995, with the number of reported cases in each decade showing a nearly linear rise. The average number of affected members from each 10,000 was 3.9. It is essential for clinicians to be aware of this disease as it has a significant impact on this patient's quality of life and may adversely affect health care and insurance costs." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in gore viabahn® endoprosthesis with heparin bioactive surface for therapeutic use?

"In the past 5 years, a new Gore® Viabahn® endoprosthesis with heparin activity-coated mesh and two new heparin-eluting valves have been introduced for aortic, mitral or tricuspid valve replacement. The new heparin-coated valves showed excellent valve function and durability up to 12 years with low thrombogenemia and anticoagulation-related events." - Anonymous Online Contributor

Unverified Answer

Has gore viabahn® endoprosthesis with heparin bioactive surface proven to be more effective than a placebo?

"Recent findings indicates that the GVEP with heparin bioactive surface can be more effective in sealing holes, compared to a control device equipped with a non bioactive surface." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating constriction, pathologic?

"There have been no new discoveries for treating constriction, pathologic. Current treatments in this area is surgery, endovascular treatment, and conservative treatment. Further research focusing on the prevention of constriction, pathologic is needed." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of gore viabahn® endoprosthesis with heparin bioactive surface?

"The blood stream infection rate (<2 %), neurological disorders (11 %), deep venous thrombosis 6.0 % and bleeding (4.7 %) were the most common of the evaluated parameters at follow-up. However, the clinical significance of the side effects is only slightly assessed in the case of infection and neurological disorders. Further randomized studies with longer follow-up times are needed to investigate if Gore's Viabahn endoprosthesis provides a safe or effective alternative to traditional balloon catheters in routine prosthetic vascular management." - Anonymous Online Contributor

Unverified Answer

Does gore viabahn® endoprosthesis with heparin bioactive surface improve quality of life for those with constriction, pathologic?

"For patients with a constriction, Gore Dural conduit with heparin-bioactive surface showed greater QOL improvement in terms of activities and social life, similar to patients with a Gore Dural conduit without heparin bioactive surface. Gore Dural® conduits with heparin-bioactive surface provide sustained lower blood loss and greater QOL improvement in constriction compared to Gore Dural conduits without heparin-bioactive surface, and Gore Dural conduits without heparin-bioactive surface should be used with caution for patients with constriction." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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