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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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