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The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous renal denervation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARADISE percutaneous renal denervation | Device | Intravascular ultrasound emission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful interventions | A successful intervention is defined by the ability to successfully:
| Up to 24 hours |
| Percentage of patients with device- or procedure-related adverse events | Anticipated adverse events include:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ambulatory blood pressure | 12 months | |
| Change from baseline in anti-hypertensive medication intake | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Montalescot, Professor | Hôpital Pitié-Salpêtrière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Toulouse et CHU | Toulouse | 1048 | France | |||
| Hôpital Pitié-Salpêtrière |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Paris |
| Île-de-France Region |
| 75013 |
| France |