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Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.
The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Renal artery stenting and Best medical treatment |
|
| 2 | Active Comparator | Best medical treatment alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herkulink renal artery Stent | Device | renal artery stent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in mean blood pressure and renal function occurrence of major cardiovascular events | 3, 6, 9, 12 months, annually |
| Measure | Description | Time Frame |
|---|---|---|
| progression of the degree of RAS in the conservative group and restenosis rate in the stent group | 6, 12 months, annually |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erich Minar, Prof. Dr. | Contact | erich.minar@meduniwien.ac.at | ||
| Martin Schillinger, Prof. Dr. | Contact | martin.schillinger@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Recruiting | Vienna | 1090 | Austria |
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| best medical therapy | Other | All patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification |
|
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| D018450 | Disease Progression |
| D050197 | Atherosclerosis |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D016491 | Peripheral Vascular Diseases |
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