NL-OMON54821
Completed
Phase 2
A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension, in the Absence of Antihypertensive Medications - The TARGET BP OFF-MED Trial
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ablative Solutions Inc
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1\. Subject has provided written informed consent.
- •2\. Male or female subject, aged \>\=18 and \<\=80 years at time of enrollment.
- •3\. If subject has a documented history of uncontrolled hypertension (see
- •definition in Definition of
- •Terms section of protocol) and is currently taking no (0\)
- •antihypertensive medications, he/she
- •o Have 3 office blood pressure measurements with a mean office SBP of \>\=140 mmHg
- •and \<\=180
- •mmHg AND mean office DBP \>\=90 mmHg, and
- •o Be willing to adhere to the no\-medication regimen for at least 12 weeks (4
Exclusion Criteria
- •1\. Subject has a contraindication known for conventional percutaneous
- •interventional procedures.
- •2\. Subject has an acute or sub\-acute infection that the investigator judges
- •would pose unacceptable procedural risks to the subject.
- •3\. Subject has imaging\-assessed renal artery anatomy abnormalities or
- •variations based on investigator's evaluation of the screening images (i.e.
- •MRA/CTA examination and/or renal angiography) meeting one of the following
- •o Main renal artery that has a diameter of \<4 mm or \>7 mm and length of \<5 mm
- •o Accessory renal arteries with diameter \>2 mm or \<4 mm, which supply \>20% of
- •the whole kidney parenchyma on that side, per the investigator's judgment.
Investigators
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