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Low Enrollment
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The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed.
Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is currently approved in the United States to deliver ion dose therapy to re-narrowings that form in the coronary arteries in the heart. This trial is assessing the safety of treating patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney to help control blood pressure in patients with uncontrolled hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation dose 25 Gy | Active Comparator | • 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. |
|
| Radiation dose 50 Gy | Active Comparator | • 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Dose 25 Gy | Radiation | Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety-renal Artery Brachytherapy With Beta-emitting Source is Any Need for Renal Artery Intervention to Treat Renal Artery Injury Induced by the Catheter of Radiation Within 6 Months | The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months | up to 6 months post procedure |
| Efficacy- Renal Artery Brachytherapy With Beta-emitting Source is Decrease in Systolic and Diastolic Blood Pressure of ≥10 mmHg at Six Months Following the Procedure. | The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure. | up to 6 months post procedure |
| Angiographic | The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA) | up to 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on Blood Pressure | Short term effects of renal artery brachytherapy on blood pressure | up to 6 months post procedure |
| Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically. |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria prior to enrollment into the trial:
4.2.2 ANGIOGRAPHIC INCLUSION CRITERIA
1. Individual has main renal arteries measuring <2.75 mm in diameter.
Exclusion Criteria:
Inability to sign written informed consent.
Individual has renal artery anatomy that is ineligible for treatment including:
Individual has an eGFR of < 45mL/min/1.73m2, using the MDRD formula calculation.
Individual has had >1 hospital admission for a hypertensive crisis within the past year.
Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP<135mmHg.
Individual has has > 1 episode(s) of orthostatic hypotension (reduction of SBP of >20 mmHg or diastolic blood pressure (DBP) of >10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Individual has primary pulmonary hypertension.
Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.
Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
Individual is pregnant, nursing or planning to be pregnant.
Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Individual is currently enrolled in another investigational drug or device trial.
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Dose 25 Gy | • 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. |
| FG001 | Radiation Dose 50 Gy | • 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
no patients were enrolled in arm two
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Dose 25 Gy | • 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety-renal Artery Brachytherapy With Beta-emitting Source is Any Need for Renal Artery Intervention to Treat Renal Artery Injury Induced by the Catheter of Radiation Within 6 Months | The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months | Not enough patients were enrolled to be analyzed | Posted | up to 6 months post procedure |
|
24 months
Radiation Dose 50 Gy: No patients were enrolled in this arm of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Dose 25 Gy | • 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Rowland | Medstar Health Research Institute | 2028772959 | megan.e.rowland@medstar.net |
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| Radiation Dose 50 Gy | Radiation | Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. |
|
Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.
| up to 24 months post procedure |
| eGFR or New Stenosis | Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure. | up to 6 months post procedure |
| Medication Changes | Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically,
| up to 24 months post procedure |
| Serious Adverse Events | Rate of any serious adverse events or device-related adverse events | up to 24 months post procedure |
| BG001 |
| Radiation Dose 50 Gy |
• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Radiation Dose 50 Gy | • 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. |
|
| Primary | Efficacy- Renal Artery Brachytherapy With Beta-emitting Source is Decrease in Systolic and Diastolic Blood Pressure of ≥10 mmHg at Six Months Following the Procedure. | The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure. | Not enough patients were enrolled to be analyzed | Posted | up to 6 months post procedure |
|
|
| Primary | Angiographic | The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA) | not enough patients were enrolled to analize data | Posted | up to 6 months post procedure |
|
|
| Secondary | Effects on Blood Pressure | Short term effects of renal artery brachytherapy on blood pressure | Not enough patients were enrolled to be analyzed | Posted | up to 6 months post procedure |
|
|
| Secondary | Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically. | Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically. | Not enough patients were enrolled to be analyzed | Posted | up to 24 months post procedure |
|
|
| Secondary | eGFR or New Stenosis | Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure. | Not enough patients were enrolled to be analyzed | Posted | up to 6 months post procedure |
|
|
| Secondary | Medication Changes | Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically,
| Not enough patients were enrolled to be analyzed | Posted | up to 24 months post procedure |
|
|
| Secondary | Serious Adverse Events | Rate of any serious adverse events or device-related adverse events | Not enough patients were enrolled to be analyzed | Posted | up to 24 months post procedure |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Radiation Dose 50 Gy | • 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months. Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. | 0 | 0 | 0 | 0 | 0 | 0 |
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