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Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004.
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The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.
A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) results in de novo or restenotic atherosclerotic renal artery stenoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenting: Renal Artery | Device | Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency . | at 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success | Acute | |
| Access site events requiring surgical repair or intervention | Acute | |
| Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ramee, M.D. | Alton Ochsner Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alton Ochsner Medical Foundation | New Orleans | Louisiana | 70121 | United States |
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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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|
| at 30 days |
| TLR | at 9 months |
| Renal function | measured at 1, 6, 9, and 12-month follow-up, and every three months thereafter until approximately May 2003 or until patient 169 completes 12 month follow-up. |
| Changes in blood pressure | 9 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |