Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (ARTISAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Atrium Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT01673373
First received: August 23, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow by the stent will help to control blood pressure.


Condition Intervention
Renal Artery Stenosis
Hypertension, Renovascular
Device: iCAST™ Rx Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • Functional Endpoint: Primary Patency [ Time Frame: 9-Months ] [ Designated as safety issue: No ]
    Assessment of primary patency rate at 9-months, defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.

  • Clinical Endpoint: Systolic Blood Pressure Improvement [ Time Frame: 9-Months ] [ Designated as safety issue: No ]
    Improvement in systolic blood pressure (SBP) at 9-months as compared to baseline systolic blood pressure.


Secondary Outcome Measures:
  • Procedure-Related Major Adverse Events (MAE) [ Time Frame: 30-Days, 9-Months, 12-Months, 24-Months, and 36-Months ] [ Designated as safety issue: Yes ]

    The occurence of procedure-related MAEs reported as a percentage of subjects with MAE. Inclusive of:

    1. Procedure- or device-related occurrence of death
    2. Q-Wave Myocardial Infarction (MI)
    3. Clinically driven Target Lesion Revascularization (TLR)
    4. Significant embolic events defined as: unanticipated kidney/bowel infarct clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery, lower extremity ulceration or gangrene, or kidney failure.

  • Technical Success [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]
    Defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.

  • Procedural Success [ Time Frame: Day of Procedure, prior to hospital discharge ] [ Designated as safety issue: No ]
    Defined as technical success without the occurrence of MAE prior to hospital discharge.

  • Target Lesion Revascularization (TLR) [ Time Frame: 9-Months ] [ Designated as safety issue: No ]

    Measured as the proportion of subjects that require a clinically-driven reintervention of the target lesion through 9-months.

    a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.


  • Rate of Incidental TLR [ Time Frame: 9-Months ] [ Designated as safety issue: No ]
    Defined as rate of TLRs not meeting the definition of a clinically driven TLR.

  • Improved Systolic Blood Pressure (SBP) Control [ Time Frame: 30-Days, 9-Months, 12-Months, 24-Months, and 36-Months ] [ Designated as safety issue: No ]
    Improved SBP control assessed at 30-days, 9-months, 12-months, 24-months and 36-months.

  • Secondary Patency Rate [ Time Frame: 9-Months ] [ Designated as safety issue: No ]
    Secondary patency rate at 9-months after a clinically-driven TLR which restores patency after total occlusion.

  • Change in Number and Dosage of Anti-Hypertensive Medications [ Time Frame: Baseline to 36-Months ] [ Designated as safety issue: No ]
    Change in number and dosage of anti-hypertensive medications as compared to baseline.

  • Change in Renal Function [ Time Frame: Baseline to 30-Days and Baseline to 9-Months ] [ Designated as safety issue: No ]
    Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30-days and 9-months.


Estimated Enrollment: 138
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iCAST RX™ Stent Systen
All enrolled subjects will receive the iCAST RX™ Stent System
Device: iCAST™ Rx Stent System
All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Other Name: iCAST™ RX

Detailed Description:

This is a prospective, single-arm, multicenter clinical trial that will take place at up to 25 US/ Outside US (OUS) sites. Primary endpoints have been determined to show the safety, effectiveness, and clinical outcomes of the iCAST™ RX Stent System. Safety and effectiveness will be evaluated based on the primary patency rate at 9-months on a per lesion basis evaluated against a performance goal of published studies with bare-metal stents. The primary clinical endpoint will assess the improvement in Systolic Blood Pressure (SBP) at 9-months as compared to baseline Systolic Blood Pressure.

Eligible subjects will undergo a two-week Medical Documentation Screening period to confirm resistant hypertension (SBP ≥ 155mmHg) while on maximum tolerable doses of ≥ three anti-hypertensive medications from at least three distinct classes of drugs, one of which must be a diuretic.

There must be documented clinical evidence to support likelihood of angiographic findings > 80% whether it is Duplex Ultrasound (DUS), Computed Tomography angiogram (CTa), Magnetic Resonance angiogram (MRa) or other medical evidence. After meeting screening and clinical eligibility criteria, subjects will undergo a baseline assessment for angiographic eligibility. After angiographic documentation of a ≥ 80% renal artery stenosis or Fraction Flow Reserve (FFR) < 0.8 is confirmed, the subject may be enrolled in the trial by placement of the investigational device.

The 9-month visit will include a follow-up DUS of the target renal artery. If the DUS is non-diagnostic due to an imaging problem, such as overlying bowel gas or body habitus, a second DUS may be attempted. If the DUS is indicative of ≥ 60% stenosis as determined by the core laboratory, or the second DUS remains non-diagnostic, a contrast angiogram will be used to assess the degree of restenosis of the covered stent(s).

Clinical follow-up visits will be required for all enrolled subjects at 30-days, 9-months, 12-months, 24-months, and 36-months. A 6-month and 18-month visit will occur via telephone to collect medication usage and Adverse Events (AEs) only. The 36-month clinic office visit will be required as the final safety visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Age ≥ 18 at the time of informed consent.
  2. Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).
  3. Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥ 155mmHg.
  4. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period).

    a. A documented history for a minimum of 3 months showing reasonable and aggressive efforts to manage hypertension prior to consent. This must include the use of a broad variety of medications that have been used and failed or not tolerated.

  5. Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence.
  6. New York Heart Association (NYHA) class I, II, or III the time of trial enrollment.

NOTE: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it is recommended to treat both kidneys with an iCAST™ RX Stent System during the index procedure. In the event that a subject needs a renal stenting procedure staged for renal protection, it is important that the Investigator treats the second renal artery with an iCAST™ RX Stent System after 30 days of the index procedure. If subjects with bilateral stenosis have only one lesion that meets protocol inclusion criteria that lesion should be treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion, however if the operator feels strongly it is indicated, then they should treat per standard of care after 30-days post index procedure in order to comply with exclusion criteria #10.

Subjects with flash pulmonary edema are allowed into the trial should they meet all other Inclusion and Exclusion criteria.

Angiographic Anatomic Inclusion Criteria:

  1. Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral renal arteries.

    a. The degree of percent diameter stenosis for all lesions intended to be treated, must be confirmed via one of the following methods: i. Manual or automated measurement with calipers ii. Measured Flow Fraction Reserve (FFR) < 0.8 using a pressure wire iii. Measured translesional peak pressure gradient of > 21mmHg after induced hyperemia via dopamine or papaverine using a 4Fr or less catheter or pressure wire.

    b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be enrolled.

  2. Renal pole-to-pole length > 8cm (per visual estimate).
  3. Target lesion length ≤ 16mm per vessel (per visual estimate).
  4. Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate).
  5. Lesion originating ≤ 15mm of the renal ostium.

General Exclusion Criteria:

  1. Subject's estimated life expectancy is < 12 months.
  2. Subject has a history of transplanted kidney(s), has had another recent organ transplant or polycystic kidney disease.
  3. Subject with estimated eGFR ≤ 25mL/min/1.73m2
  4. Subject has a history of bleeding diathesis or coagulopathy or refuses blood transfusions.
  5. Subject has a known contraindication to heparin, aspirin, thienopyridine, other anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or polytetrafluoroethylene (PTFE).
  6. Subject has had a previous renal bypass operation, a bypass is planned, or the target lesion is located within or beyond a bypass graft.
  7. Subject has received a thrombolytic agent within the past 30 days.
  8. Subject has documented acute pulmonary edema or systolic heart failure with ejection fraction < 30% and/or hospitalization requiring intubation and ventilation support for this diagnosis within the previous 90 days or hypertensive emergencies defined as resulting in organ damage.
  9. Concurrent enrollment in any investigational trial wherein subject's participation has not been completed.
  10. Subject has had a planned or anticipated cardiovascular surgical or interventional procedure outside of the affected renal artery (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to the index procedure and prior to completion of the 30 day follow-up.
  11. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months.
  12. Subject is pregnant, lactating, or is of child-bearing potential and plans to become pregnant during the follow-up trial period.
  13. Subject with significant valvular disease.
  14. Subject with known significant proteinuria > 2+ or > 2.0gm/d.
  15. Subject with known bilateral upper-extremity arterial stenosis that result in spuriously low arm pressures or without the ability to gain reliable blood pressure measurements in at least one upper extremity.
  16. Subject with active sepsis.
  17. Subject with serum creatinine ≥ 3.0mg/dL.
  18. Subject with NYHA Class IV at the time of enrollment.
  19. Subject is on hemodialysis.
  20. Subject has a history of renal aneurysm.
  21. Subject with cardiogenic shock.
  22. Subject with cardiomyopathy.
  23. Subject has an uncontrolled concurrent illness, including but not limited to ongoing or active infection or active autoimmune disease requiring immunosuppressive therapy.
  24. Any subject with clinically significant cardiovascular, respiratory, neurologic, hepatic, endocrine, major systematic disease, making implementation or interpretation of the protocol or protocol results difficult or who in the opinion of the investigator would not be a good candidate for enrollment.

Angiographic Anatomic Exclusion Criteria:

  1. The planned site of intervention is totally occluded or has an anatomic configuration likely to prohibit adequate dilatation, and/or passage or implantation of the investigational device.
  2. Subject has multiple ipsilateral lesions of the target renal artery that cannot be covered by a single stent.
  3. There is a previously implanted stent in the target vessel or there is a previously implanted stent in the contralateral vessel < one year.
  4. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed.
  5. The target lesion site is associated with a thrombus.
  6. Target lesion treated with laser atherectomy, directional atherectomy or other adjuncts to PTA.
  7. Subject has a critical stenotic (> 70%) small accessory renal artery.
  8. Subject has an abdominal aortic aneurysm > 4.0cm in diameter or a severe atherosclerotic aorta.
  9. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal stent.
  10. Any lesion that would include blocking of renal artery side branch.
  11. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673373

Contacts
Contact: Leah Hollins 603-880-1433 ext 5365 lhollins@atriummed.com

  Hide Study Locations
Locations
United States, Arizona
Arizona Heart Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact: Greg Ortiz    602-604-5211    gnortiz@abrazohealth.com   
Principal Investigator: Venkatesh Ramaiah, MD         
United States, California
Mission Cardiovascular Research Institute Recruiting
Fremont, California, United States, 94538
Contact: Jimmin Chang    510-796-0222    jchang@cccma.org   
Principal Investigator: Ash Jain, MD         
Radiological Associates of Sacramento Withdrawn
Sacramento, California, United States, 95815
United States, Colorado
Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80538
Contact: Adam Jaskowiak    970-624-1688    ajj4@pvhs.org   
Principal Investigator: William Miller, MD         
United States, District of Columbia
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact: Muluemebet Ketete    202-865-4878    mketete@howard.edu   
Principal Investigator: Otelio Randall, MD         
Principal Investigator: Prithviraj Rai, MD         
United States, Florida
Clearwater Cardiovascular and Interventional Consultants Recruiting
Clearwater, Florida, United States, 33756
Contact: Amy Davidson    727-467-9393    DavidsonA@cccheart.com   
Principal Investigator: Saihari Sadanandan, MD         
Baptist Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Ivette Cruz    786-596-4746    IvetteC@baptisthealth.net   
Principal Investigator: Constantino Pena, MD         
United States, Illinois
Advocate Health and Hospitals Corporation Recruiting
Naperville, Illinois, United States, 60563
Contact: Kim Paprockas    630-873-3404    kimberly.paprockas@advocatehealth.com   
Contact: Alice Szydlowska    630-268-9609    alicja.szydlowska@advocatehealth.com   
Principal Investigator: Mark Goodwin, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Monique Robert       monique.robert@tgmc.com   
Principal Investigator: Craig Walker, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: NurAlima Grandison    617-643-1372    ngrandison@partners.org   
Principal Investigator: Douglas Drachman, MD         
United States, Michigan
Beaumont Health Systems Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Dorothy Richardson    248-898-9161    drichardson@beaumont.edu   
Principal Investigator: Amr Abbas, MD         
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Yitzchak David       y-david@mail.holyname.org   
Principal Investigator: John Rundback, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Elana Pessin    212-241-1547    elana.pessin@mountsinai.org   
Principal Investigator: Robert Lookstein, MD         
United States, North Carolina
Mid Carolina Cardiology Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Pailing Richards       pcrichards@novanthealth.org   
Principal Investigator: Michael Miller, MD         
Wake Heart and Vascular Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Meredith Shillingaw    919-418-8391    mshillinglaw@wakeheartresearch.com   
Principal Investigator: Ravish Sachar, MD         
United States, Ohio
University Hospitals Medical Group Recruiting
Cleveland, Ohio, United States, 44106
Contact: Terrence Semenec    216-983-4724    terence.semenec@uhhospitals.org   
Principal Investigator: Sahil Parikh, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adreinne Harvey    216-444-2331    harveya2@ccf.org   
Principal Investigator: Mehdi Shishehbor, DO         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Beth Archer    614-566-1252    barcher@ohiohealth.com   
Principal Investigator: Mitchell Silver, DO         
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Stephanie Marts    419-383-3853    Stephanie.Marts@utoledo.edu   
Principal Investigator: Mark Burket, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Brandy Venable, RN    423-230-5643    BVenable@mycva.com   
Principal Investigator: Christopher Metzger, MD         
United States, Texas
Austin Heart, PLLC Recruiting
Austin, Texas, United States, 78756
Contact: Paige Musick, RN    512-421-3896    paige.musick@hcahealthcare.com   
Principal Investigator: Frank Zidar, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Jessica Jones    469-814-4738    Jessica.Jones1@BaylorHealth.edu   
Principal Investigator: David Brown, MD         
United States, Washington
Swedish Medical Center Withdrawn
Seattle, Washington, United States, 98122
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Joy Hogan    304-388-9957    joy.hogan@camc.org   
Principal Investigator: Aravinda Nanjundappa, MD         
United States, Wisconsin
Wheaton Franciscan Medical Group Recruiting
Racine, Wisconsin, United States, 53405
Contact: Anthony Alonge    262-687-8177    anthony.alonge@wfhc.org   
Principal Investigator: Thomas Shimshak, MD         
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
Principal Investigator: Gary M Ansel, MD MidOhio Cardiology and Vascular Consultants
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT01673373     History of Changes
Other Study ID Numbers: iCAST™ RX-ARAS-001
Study First Received: August 23, 2012
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Atrium Medical Corporation:
Renal Artery Stenosis
Renal Artery Obstruction
Renovascular Hypertension
Resistant Hypertension
Renal Revascularization
Atherosclerotic Renal Artery Stenosis
ARAS (Atherosclerotic Renal Artery Stenosis)
RAS (Renal Artery Stenosis)
Uncontrolled hypertension
Hypertension
systolic blood pressure
blood pressure

Additional relevant MeSH terms:
Constriction, Pathologic
Hypertension
Hypertension, Renovascular
Renal Artery Obstruction
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Hypertension, Renal
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 26, 2014