Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propaten graft | Active Comparator |
| |
| Standard graft | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic AV graft implantation | Procedure | Surgical arteriovenous fistula creation with standard or propaten graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency of AV fistula | Study period |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center, Jerusalem | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25770987 | Derived | Shemesh D, Goldin I, Hijazi J, Zaghal I, Berelowitz D, Verstandig A, Olsha O. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg. 2015 Jul;62(1):115-22. doi: 10.1016/j.jvs.2015.01.056. Epub 2015 Mar 12. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 14, 2015 | |
| Reset | Jul 9, 2015 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2015 | Jul 9, 2015 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |