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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
| Johnson & Johnson | INDUSTRY |
This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.
This study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (RAS) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination.
Specific goals of the study include:
The study will address the four following hypotheses:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Artery Stent with Protective Device/Drug | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate | ||
| Adverse Events |
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Inclusion Criteria:
Any one or more of the following:
Meet Angiographic criteria plus
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cooper, M.D. | Medical University of Ohio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Ohio | Toledo | Ohio | 43614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. | |
| 21908683 | Derived | Yu H, Zhang D, Haller S, Kanjwal K, Colyer W, Brewster P, Steffes M, Shapiro JI, Cooper CJ. Determinants of renal function in patients with renal artery stenosis. Vasc Med. 2011 Oct;16(5):331-8. doi: 10.1177/1358863X11419998. Epub 2011 Sep 9. |
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| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 20823380 | Derived | Tian J, Haller S, Periyasamy S, Brewster P, Zhang H, Adlakha S, Fedorova OV, Xie ZJ, Bagrov AY, Shapiro JI, Cooper CJ. Renal ischemia regulates marinobufagenin release in humans. Hypertension. 2010 Nov;56(5):914-9. doi: 10.1161/HYPERTENSIONAHA.110.155564. Epub 2010 Sep 7. |
| 20209644 | Derived | Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW, Steffes M, Brewster P, Zhang H, Colyer WR Jr. Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):16-23. doi: 10.1002/ccd.22469. |
| 19198007 | Derived | Kanjwal K, Haller S, Steffes M, Virmani R, Shapiro JI, Burket MW, Cooper CJ, Colyer WR Jr. Complete versus partial distal embolic protection during renal artery stenting. Catheter Cardiovasc Interv. 2009 May 1;73(6):725-30. doi: 10.1002/ccd.21932. |
| 18490527 | Derived | Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, Khuder S. Embolic protection and platelet inhibition during renal artery stenting. Circulation. 2008 May 27;117(21):2752-60. doi: 10.1161/CIRCULATIONAHA.107.730259. Epub 2008 May 19. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |