Trial Outcomes & Findings for Renal Denervation in Patients With Uncontrolled Blood Pressure (NCT NCT01968785)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

up to 6 months post procedure

Results posted on

2022-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	2	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Renal Denervation in Patients With Uncontrolled Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Dose 25 Gy n=2 Participants • 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.	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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months post procedure

Population: Not enough patients were enrolled to be analyzed

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 6 months post procedure

Population: Not enough patients were enrolled to be analyzed

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 6 months post procedure

Population: not enough patients were enrolled to analize data

The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months post procedure

Population: Not enough patients were enrolled to be analyzed

Short term effects of renal artery brachytherapy on blood pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months post procedure

Population: Not enough patients were enrolled to be analyzed

Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months post procedure

Population: Not enough patients were enrolled to be analyzed

Estimated glomerular filtration rate (eGFR) drop \>25% or new renal artery stenosis \> 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months post procedure

Population: Not enough patients were enrolled to be analyzed

Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically, 1. Additions, changes and cessation of medications 2. Dosage changes throughout the follow up duration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months post procedure

Population: Not enough patients were enrolled to be analyzed

Rate of any serious adverse events or device-related adverse events

Outcome measures

Outcome data not reported

Adverse Events

Radiation Dose 25 Gy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Radiation Dose 50 Gy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiation Dose 25 Gy n=2 participants at risk • 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.	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.
Musculoskeletal and connective tissue disorders Jaw Pain	50.0% 1/2 • Number of events 1 • 24 months Radiation Dose 50 Gy: No patients were enrolled in this arm of the study	— 0/0 • 24 months Radiation Dose 50 Gy: No patients were enrolled in this arm of the study

Additional Information

Megan Rowland

Medstar Health Research Institute

Phone: 2028772959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place