NL-OMON50148撤回不适用
Global Clinical Study of Renal Denervation in the distal main and first order branch renal arteries using the Symplicity SpyralTM multi-electrode renal denervation system (SPYRAL DYSTAL) - SPYRAL DYSTA
Medtronic Trading NL BV0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Individual is * 20 and * 80 years old at time of enrollment (consent).
- •2. Individual has an office systolic blood pressure (SBP) * 150 mmHg and < 180
- •mmHg and an office diastolic blood pressure (DBP) * 90 mmHg measured at
- •Screening Visit 2, according to the guidelines in Appendix 16.5.
- •3. Individual has a valid 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
- •average SBP *140 mmHg and < 170 mmHg measured at Screening Visit 2, according
- •to guidelines in Appendix 16.5
- •a) ABPM is considered valid if the number of successful daytime readings
- •captured is * 21 and the number of successful nighttime readings captured *12.
- •4. Individual agrees to have all study procedures performed, and is competent
- •and willing to provide written, informed consent to participate in this
- •clinical study.
- •5. Individual is willing to discontinue current antihypertensive medications at
- •Screening Visit 1 through the 3-month post-procedure visit.
排除标准
- •1. Individual has one or more of the following conditions: stable or unstable
- •angina within 3 months of enrollment, myocardial infarction within 3 months of
- •enrollment; heart failure, cerebrovascular accident or transient ischemic
- •attack, or atrial fibrillation at any time. Patients are permitted to take
- •aspirin or clopidogrel for cardiovascular risk reduction. Patients who received
- •catheter or surgical treatment for Atrial Fibrillation and are in sinus rhythm
- •are not excluded.
- •2. Individual has undergone prior renal denervation.
- •3. Individual has at least one main renal artery with a diameter of less than
- •3mm or greater than 8mm.
- •4. Presence of FMD (defined as visible beading of the artery on angiography).
- •5. Has >50% stenosis in any treatable vessel.
- •6. Has a renal artery stent placed <3 months prior to the denervation procedure.
- •7. Presence of a renal artery aneurysm defined as any localized increase in the
- •diameter of the vessel.
- •8. Disease not allowing any treatment in the main renal artery.
- •9. Individual has an estimated glomerular filtration rate (eGFR) of <45
- •mL/min/1.73m2, using the 4 variable MDRD calculation (in mL/min per 1.73 m2 =
- •175 x SerumCr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if
- •10. Individual has documented type 1 diabetes mellitus or poorly-controlled
- •type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%. (If
- •the glycosylated hemoglobin in the patient*s records is >3 months old (from the
- •date of Screening Visit 2), or history of uncontrolled blood sugars raises
- •concern, it is required to analyze glycosylated hemoglobin as part of Screening
- •Visit 2 labs.)
- •11. Individual is taking SGLT2 inhibitor or GLP-1 agonists that have been
- •prescribed <90 days prior to SV1 or who does not plan on remaining on these
- •drugs for the duration of the trial.
- •12. Individual has had *1 episode(s) of orthostatic hypotension not related to
- •medication changes within the past year or has a reduction of SBP *20 mmHg or
- •DBP *10 mmHg within 3 minutes of standing coupled with symptoms during the
- •screening process (at SV2).
- •13. Individual requires chronic oxygen support or mechanical ventilation other
- •than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP).
- •14. Individual with a history of narcotic drug abuse, is currently on
- •Methadone, or who has used narcotic drugs more than once in the month prior to
- •Screening Visit 1.
- •15. Individual had documented primary pulmonary hypertension.
- •16. Individual has untreated secondary cause of hypertension (either known or
- •suspected) or is taking drugs that increase sympathetic tone that could
- •contribute to hypertension.
- •17. Individual has frequent intermittent or chronic pain that results in
- •treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two or more
- •days per week over the month prior to Screening Visit 2.
- •18. Individual with HIV on anti-retroviral drug therapy without documentation
- •that hypertension preceded initiation of anti-retroviral drug treatment.
- •19. Individual has a scheduled or planned surgery that, in the opinion of the
- •Investigator, may affect study endpoints.
- •20. Individual has a documented condition that would prohibit or interfere with
- •ability to obtain an accurate blood pressure measurement using the
- 另有 1 项未显示
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