search
Back to results

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

Primary Purpose

Renal Artery Stenosis, Hypertension, Renovascular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCAST™ Rx Stent System
Sponsored by
Atrium Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Artery Stenosis focused on measuring Renal Artery Stenosis, Renal Artery Obstruction, Renovascular Hypertension, Resistant Hypertension, Renal Revascularization, Atherosclerotic Renal Artery Stenosis, Atherosclerotic Renal Artery Stenosis (ARAS), Renal Artery Stenosis (RAS), Uncontrolled hypertension, Hypertension, Systolic blood pressure, Blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 > 21 mmHg after induced hyperemia via dopamine or papaverine using a 4 Fr 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 glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2
  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 percutaneous balloon angioplasty (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.

Sites / Locations

  • Mission Cardiovascular Research Institute
  • Medical Center of the Rockies
  • Clearwater Cardiovascular and Interventional Consultants
  • Advocate Health and Hospitals Corporation
  • Massachusetts General Hospital
  • Beaumont Health Systems
  • Holy Name Medical Center
  • Mid Carolina Cardiology
  • NC Heart and Vascular Research
  • OhioHealth Research Institute
  • Wellmont CVA Heart Institute
  • Tennova Healthcare - Turkey Creek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iCAST RX™ Stent Systen

Arm Description

All enrolled subjects will receive the iCAST RX™ Stent System

Outcomes

Primary Outcome Measures

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.
Systolic Blood Pressure
Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.

Secondary Outcome Measures

Procedure-Related Major Adverse Events (MAE)
The occurence of procedure-related MAEs is 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
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.
Acute Procedural Success
Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.
Target Lesion Revascularization (TLR)
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.
Rate of Incidental TLR
The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.
Systolic Blood Pressure (SBP) Control
The change in SBP from baseline to 30 days
SBP Control
The change in SBP from baseline to 9 months
Secondary Patency Rate
Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.
Change in Number of Anti-Hypertensive Medications
Change in number of anti-hypertensive medications as compared to baseline.
Change in Renal Function
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.
Change in Renal Function
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.

Full Information

First Posted
August 23, 2012
Last Updated
November 5, 2020
Sponsor
Atrium Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01673373
Brief Title
Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension
Acronym
ARTISAN
Official Title
ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2012 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atrium Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis, Hypertension, Renovascular
Keywords
Renal Artery Stenosis, Renal Artery Obstruction, Renovascular Hypertension, Resistant Hypertension, Renal Revascularization, Atherosclerotic Renal Artery Stenosis, Atherosclerotic Renal Artery Stenosis (ARAS), Renal Artery Stenosis (RAS), Uncontrolled hypertension, Hypertension, Systolic blood pressure, Blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCAST RX™ Stent Systen
Arm Type
Experimental
Arm Description
All enrolled subjects will receive the iCAST RX™ Stent System
Intervention Type
Device
Intervention Name(s)
iCAST™ Rx Stent System
Other Intervention Name(s)
iCAST™ RX
Intervention Description
All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Primary Outcome Measure Information:
Title
Primary Patency
Description
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
Title
Systolic Blood Pressure
Description
Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.
Time Frame
Baseline and 9 months
Secondary Outcome Measure Information:
Title
Procedure-Related Major Adverse Events (MAE)
Description
The occurence of procedure-related MAEs is 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.
Time Frame
30 days, 9 months
Title
Technical Success
Description
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
Title
Acute Procedural Success
Description
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
Title
Target Lesion Revascularization (TLR)
Description
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
Title
Rate of Incidental TLR
Description
The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.
Time Frame
9 months
Title
Systolic Blood Pressure (SBP) Control
Description
The change in SBP from baseline to 30 days
Time Frame
Baseline and 30 days
Title
SBP Control
Description
The change in SBP from baseline to 9 months
Time Frame
Baseline and 9 months
Title
Secondary Patency Rate
Description
Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.
Time Frame
9 months
Title
Change in Number of Anti-Hypertensive Medications
Description
Change in number of anti-hypertensive medications as compared to baseline.
Time Frame
Baseline and 9 months
Title
Change in Renal Function
Description
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.
Time Frame
Baseline and 30 days
Title
Change in Renal Function
Description
Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.
Time Frame
Baseline and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria: Age ≥ 18 at the time of informed consent. 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). 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. 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. Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence. 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: 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 > 21 mmHg after induced hyperemia via dopamine or papaverine using a 4 Fr or less catheter or pressure wire. b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be enrolled. Renal pole-to-pole length > 8cm (per visual estimate). Target lesion length ≤ 16mm per vessel (per visual estimate). Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate). Lesion originating ≤ 15mm of the renal ostium. General Exclusion Criteria: Subject's estimated life expectancy is < 12 months. Subject has a history of transplanted kidney(s), has had another recent organ transplant or polycystic kidney disease. Subject with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 Subject has a history of bleeding diathesis or coagulopathy or refuses blood transfusions. Subject has a known contraindication to heparin, aspirin, thienopyridine, other anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or polytetrafluoroethylene (PTFE). Subject has had a previous renal bypass operation, a bypass is planned, or the target lesion is located within or beyond a bypass graft. Subject has received a thrombolytic agent within the past 30 days. 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. Concurrent enrollment in any investigational trial wherein subject's participation has not been completed. 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. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months. Subject is pregnant, lactating, or is of child-bearing potential and plans to become pregnant during the follow-up trial period. Subject with significant valvular disease. Subject with known significant proteinuria > 2+ or > 2.0gm/d. 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. Subject with active sepsis. Subject with serum creatinine ≥ 3.0mg/dL. Subject with NYHA Class IV at the time of enrollment. Subject is on hemodialysis. Subject has a history of renal aneurysm. Subject with cardiogenic shock. Subject with cardiomyopathy. Subject has an uncontrolled concurrent illness, including but not limited to ongoing or active infection or active autoimmune disease requiring immunosuppressive therapy. 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: 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. Subject has multiple ipsilateral lesions of the target renal artery that cannot be covered by a single stent. There is a previously implanted stent in the target vessel or there is a previously implanted stent in the contralateral vessel < one year. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed. The target lesion site is associated with a thrombus. Target lesion treated with laser atherectomy, directional atherectomy or other adjuncts to percutaneous balloon angioplasty (PTA). Subject has a critical stenotic (> 70%) small accessory renal artery. Subject has an abdominal aortic aneurysm > 4.0cm in diameter or a severe atherosclerotic aorta. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal stent. Any lesion that would include blocking of renal artery side branch. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Rosenfield, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Ansel, MD
Organizational Affiliation
OhioHealth Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mission Cardiovascular Research Institute
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Clearwater Cardiovascular and Interventional Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Advocate Health and Hospitals Corporation
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beaumont Health Systems
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Mid Carolina Cardiology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
NC Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Tennova Healthcare - Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs