Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (ARTISAN)
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.
Renal Artery Stenosis
Device: iCAST™ Rx Stent System
|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|
- 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.
- 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:
- Procedure- or device-related occurrence of death
- Q-Wave Myocardial Infarction (MI)
- Clinically driven Target Lesion Revascularization (TLR)
- 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 eGFR at 30-days and 9-months.
|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)|
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
This is a prospective, single-arm, multicenter clinical trial that will take place at up to 25 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.
Severe renal artery stenosis must be confirmed by a core laboratory adjudicated Duplex Ultrasound (DUS) prior to consideration for enrollment. DUS taken within 12 weeks prior to the index procedure that have been reviewed and approved by the core laboratory will be accepted to satisfy entry criteria. 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 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.
|Contact: Leah Hollins||603-880-1433 ext firstname.lastname@example.org|
|United States, California|
|Radiological Associates of Sacramento||Recruiting|
|Sacramento, California, United States, 95815|
|Contact: Christina Dyer 916-561-8657 email@example.com|
|Principal Investigator: Mark Davidian, MD|
|United States, Colorado|
|Medical Center of the Rockies||Recruiting|
|Loveland, Colorado, United States, 80538|
|Contact: Adam Jaskowiak 970-624-1688 firstname.lastname@example.org|
|Principal Investigator: William Miller, MD|
|United States, Illinois|
|Advocate Health and Hospitals Corporation||Recruiting|
|Naperville, Illinois, United States, 60563|
|Contact: Kim Paprockas 630-873-3404 email@example.com|
|Contact: Alice Szydlowska 630-268-9609 firstname.lastname@example.org|
|Principal Investigator: Mark Goodwin, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Deborah O'Shaughnessy 617-726-3057 email@example.com|
|Principal Investigator: Douglas Drachman, MD|
|United States, Michigan|
|Beaumont Health Systems||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Dorothy Richardson 248-898-9161 firstname.lastname@example.org|
|Principal Investigator: Amr Abbas, MD|
|United States, New Jersey|
|Holy Name Medical Center||Recruiting|
|Teaneck, New Jersey, United States, 07666|
|Contact: Yitzchak David email@example.com|
|Principal Investigator: John Rundback, MD|
|United States, North Carolina|
|Mid Carolina Cardiology||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Hazel Hill, RN 704-264-1400|
|Principal Investigator: Michael Miller, MD|
|Wake Heart and Vascular||Recruiting|
|Raleigh, North Carolina, United States, 27610|
|Contact: Joy Bongiorno 919-231-8253 firstname.lastname@example.org|
|Principal Investigator: Ravish Sachar, MD|
|United States, Ohio|
|Ohio Health Research Institute||Recruiting|
|Columbus, Ohio, United States, 43214|
|Contact: Cheryl Crabtree 614-566-1270 email@example.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: Scott Honeycutt 423-230-5643 firstname.lastname@example.org|
|Principal Investigator: Christopher Metzger, MD|
|United States, Texas|
|Austin Heart, PLLC||Recruiting|
|Austin, Texas, United States, 78756|
|Contact: Paige Musick, RN 512-421-3896 email@example.com|
|Principal Investigator: Frank Zidar, MD|
|United States, Washington|
|Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98122|
|Contact: Jeremy Gillis 206-215-2437 firstname.lastname@example.org|
|Principal Investigator: Robert Bersin, MD|
|United States, West Virginia|
|CAMC Clinical Trials Center||Recruiting|
|Charleston, West Virginia, United States, 25304|
|Contact: Jessica Parker 304-388-8199 email@example.com|
|Principal Investigator: Aravinda Nanjundappa, MD|
|Principal Investigator:||Gary M Ansel, MD||MidOhio Cardiology and Vascular Consultants|
|Principal Investigator:||Kenneth Rosenfield, MD||Massachusetts General Hospital|