The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

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Brief Title

The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

Official Title

The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

Brief Summary

      This study will test the safety and efficacy of the Vessix Renal Denervation system in the
      reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
    

Detailed Description

      This study will employ the Vessix Renal Denervation System (Boston Scientific) to ablate the
      renal nerve by radio-ablation in patients suffering from severe pain due to Autosomal
      Dominant Polycystic Kidney Disease (ADPKD). Twenty patients with opiate-dependent, Autosomal
      Dominant Polycystic Kidney Disease-associated kidney pain will be selected to this
      double-blind, prospective device study. Subjects will be randomly assigned to an experimental
      (those who will receive nerve ablation) or control (those who will have a sham procedure in
      which the ablation device is not turned on) groups. Subjects will complete physical exams and
      be administered questionnaires regarding their mental status and pain before, during and
      after the denervation procedure. Renal function and adverse events will be monitored for 1
      year after denervation.
    


Study Type

Interventional


Primary Outcome

Number of adverse events

Secondary Outcome

 Change in pain

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Vessix

Study Arms / Comparison Groups

 Experimental
Description:  Subjects will receive renal denervation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

December 2016

Completion Date

May 2020

Primary Completion Date

May 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Diagnosis of ADPKD (meeting Pei's revised criteria24).

          -  History of chronic debilitating kidney pain for >6 months due to ADPKD. Other
             approaches to pain management will have been appropriately considered and used
             including step wise treatment with non-opiates, opiates, physical therapy and where
             other non-renal causes of pain have been effectively ruled out (for example:
             pancreatitis, cholecystitis, etc).

          -  Demonstrate either opiate dependence for at least 3 months, OR partial or full medical
             disability OR self-reported significant decreased quality of life OR a minimum pain
             rating of 7 out of 10 on three consecutive occasions between screening and
             intervention

          -  Patients must be clinically able to tolerate sedation for the procedure

          -  Must be able to travel to study site.

          -  Able to provide informed consent

          -  No renal artery stenosis > 50% and presence of suitable renal artery calibers; 4-7mm
             identified at the time of renal artery catheterization

          -  Sufficient renal imaging to exclude genitourinary obstruction, tumor or other
             clinically significant pathologies associated with kidney pain.

          -  Stable renal function for a minimum of 1 month prior to study enrollment or already on
             dialysis

          -  No change in antihypertensive therapy for 1 month prior to study enrollment

          -  Women of childbearing potential must be using at least 2 acceptable forms of birth
             control

        Exclusion Criteria:

          -  Individual has renal artery anatomy that is ineligible for treatment including:

               -  Lacks at least one renal artery for each kidney with ≥ 4 mm diameter and with ≥
                  20 mm treatable length prior to a significant arterial branch

               -  Renal artery stenosis (>50%) or renal artery aneurysm in a renal artery on the
                  intervention side

               -  A history of prior renal artery intervention including balloon angioplasty or
                  stenting, or prior renal denervation procedure.

               -  Renal arteries which contain calcification or diffuse vessel abnormality which
                  does not allow at least 4 ablations to be delivered

               -  Diffuse fibromuscular dysplasia which does not allow at least 4 ablations to be
                  delivered; defined as visible beading of the artery on angiography

               -  Solitary or horseshoe kidney

          -  The presence of diabetes mellitus

          -  Individual has had ≥ 1 episode(s) of orthostatic hypotension not related to medication
             changes (reduction of systolic blood pressure of ≥20 mmHg or diastolic blood pressure
             of ≥10 mmHg within 3 minutes of standing), coupled with symptoms, within the past year
             or during the screening process.

          -  Change in systolic blood pressure associated with symptoms of orthostasis

          -  Individual requires chronic oxygen support or mechanical ventilation other than
             nocturnal respiratory support for sleep apnea.

          -  The presence of primary pulmonary hypertension

          -  The presence of other known secondary forms of hypertension such as pheochromocytoma,
             Cushing's Disease (adrenal insufficiency), primary hyperaldosteronism, coarctation of
             the aorta.

          -  Individual has experienced a myocardial infarction within 3 months of the screening
             period, or has experienced unstable angina pectoris, syncope, or a cerebrovascular
             accident within 3 months of the screening period.

          -  Individual has a scheduled or planned surgery within 1 year of study enrollment

          -  Inability to complete protocol blood pressure measurements (e.g., arm diameter too
             large for the cuff).

          -  Individual has severe cardiac valve stenosis for which, in the opinion of the
             investigator, a significant reduction of blood pressure is contraindicated.

          -  Subjects on beta blockers and or clonidine

          -  Individual has a confounding medical condition, which in the opinion of the
             investigator, may adversely affect the safety of the participant (e.g., significant
             peripheral vascular disease, abdominal aortic aneurysm, severe chronic obstructive
             pulmonary disorder)

          -  Significant bleeding diathesis (thrombocytopenia, hemophilia, or significant anemia)

          -  Individual is pregnant, nursing or planning to get pregnant within two years of study
             enrollment.

          -  Individual has a known unresolved history of drug use or alcohol dependency, who in
             the opinion of the Principal Investigator lacks the ability to comprehend or follow
             instructions, or would be unlikely or unable, in the opinion of the investigator, to
             comply with study follow-up requirements

          -  Individual with a previous solid organ transplant

          -  Individual who has had a celiac plexus block or splanchnic nerve block for pain relief
             Transcutaneous electrical nerve stimulation (TENS), spinal cord stimulation,
             acupuncture or the use of medical marijuana for pain relief within the past 3 months

          -  Hospitalization for non-pain related conditions within the past 3 months

          -  Surgical treatment for ADPKD pain relief in the past 24 months (Cyst aspiration,
             sclerotherapy and cyst fenestration surgery)

          -  Individuals with significant kidney stones (> 7-8 mm) on imaging studies

          -  Subjects with acute kidney Injury in the past 6 months

          -  Subjects with significant renal impairment (defined as glomerular filtration rate < 30
             ml/min/1.73m2 determined by chronic kidney disease equation

          -  Individual is a participant in another interventional clinical trial

          -  Subjects with an additional accessory renal vessel that perfuses more than 25% of the
             kidney

          -  Individuals with terminal illness with expected survival of less than 1 year

          -  Current symptoms of cerebral hypoperfusion (e.g. dizziness or lightheadedness, visual
             blurring or darkening of the visual fields, syncope).

          -  Acute coronary syndrome (by standard criteria) within the prior month (established by
             biomarkers of myocardial anatomy and/or electrocardiogram changes

          -  Coronary revascularization procedures within 30 days of screening, or, expected
             procedures within the next 6 months.

          -  Valve surgery within 30 days of screening, or, expected procedures within the next 6
             months.

          -  Cardiac resynchronization therapy, with or without implantable cardiac defibrillator
             within 90 days of screening or expected procedures within the next 6 months.

          -  Hypertrophic or restrictive cardiomyopathy

          -  Constrictive pericarditis

          -  Active myocarditis or endocarditis

          -  Complex congenital heart disease

          -  Severe, advanced heart failure
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02746419

Organization ID

IRB15-1484


Responsible Party

Sponsor

Study Sponsor

University of Chicago


Study Sponsor

, , 


Verification Date

March 2019