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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Mission Cardiovascular Research Institute
Fremont, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States
Primary Patency
Primary patency rate at 9 months was 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.
Time frame: 9 months
Systolic Blood Pressure
Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.
Time frame: Baseline and 9 months
Procedure-Related Major Adverse Events (MAE)
The occurence of procedure-related MAEs is 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.
Time frame: 30 days, 9 months
Technical Success
Technical success is 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.
Time frame: Day of Procedure
Acute Procedural Success
Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.
Time frame: Day of Procedure, prior to hospital discharge
Target Lesion Revascularization (TLR)
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Advocate Health and Hospitals Corporation
Naperville, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beaumont Health Systems
Royal Oak, Michigan, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
OhioHealth Research Institute
Columbus, Ohio, United States
...and 2 more locations
Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions 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.
Time frame: 9 months
Rate of Incidental TLR
The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.
Time frame: 9 months
Systolic Blood Pressure (SBP) Control
The change in SBP from baseline to 30 days
Time frame: Baseline and 30 days
SBP Control
The change in SBP from baseline to 9 months
Time frame: Baseline and 9 months
Secondary Patency Rate
Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.
Time frame: 9 months
Change in Number of Anti-Hypertensive Medications
Change in number of anti-hypertensive medications as compared to baseline.
Time frame: Baseline and 9 months
Change in Renal Function
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.
Time frame: Baseline and 30 days
Change in Renal Function
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.
Time frame: Baseline and 9 months