Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (ARTISAN)
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|ClinicalTrials.gov Identifier: NCT01673373|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2012
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Artery Stenosis Hypertension, Renovascular||Device: iCAST™ Rx Stent System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension|
|Actual Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
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
- Functional Endpoint: Primary Patency [ Time Frame: 9-Months ]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 ]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 ]
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 ]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 ]Defined as technical success without the occurrence of MAE prior to hospital discharge.
- Target Lesion Revascularization (TLR) [ Time Frame: 9-Months ]
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 ]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 ]Improved SBP control assessed at 30-days, 9-months, 12-months, 24-months and 36-months.
- Secondary Patency Rate [ Time Frame: 9-Months ]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 ]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 ]Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30-days and 9-months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673373
|United States, California|
|Mission Cardiovascular Research Institute|
|Fremont, California, United States, 94538|
|United States, Colorado|
|Medical Center of the Rockies|
|Loveland, Colorado, United States, 80538|
|United States, Florida|
|Clearwater Cardiovascular and Interventional Consultants|
|Clearwater, Florida, United States, 33756|
|United States, Illinois|
|Advocate Health and Hospitals Corporation|
|Naperville, Illinois, United States, 60563|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Beaumont Health Systems|
|Royal Oak, Michigan, United States, 48073|
|United States, New Jersey|
|Holy Name Medical Center|
|Teaneck, New Jersey, United States, 07666|
|United States, North Carolina|
|Mid Carolina Cardiology|
|Charlotte, North Carolina, United States, 28204|
|NC Heart and Vascular Research|
|Raleigh, North Carolina, United States, 27610|
|United States, Ohio|
|OhioHealth Research Institute|
|Columbus, Ohio, United States, 43214|
|United States, Tennessee|
|Wellmont CVA Heart Institute|
|Kingsport, Tennessee, United States, 37660|
|Tennova Healthcare - Turkey Creek Medical Center|
|Knoxville, Tennessee, United States, 37934|
|Principal Investigator:||Ken Rosenfield, MD||Massachusetts General Hospital|
|Principal Investigator:||Gary Ansel, MD||OhioHealth Research Institute|