Clinical Trial: Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension
Brief Summary: 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.
Detailed Summary:
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-d
Sponsor: Atrium Medical Corporation
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
- 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 eGFR at 30-days and 9-months.
Information By: Atrium Medical Corporation
Dates:
Date Received: August 23, 2012
Date Started: October 2012
Date Completion: December 2020
Last Updated: February 23, 2017
Last Verified: February 2017
