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

NCT01673373 | Completed Results DMC

• 1 other identifier: iCAST™ RX-ARAS-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  9 months

• Systolic Blood Pressure

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

  Baseline and 9 months

Secondary Outcomes (11)

• Procedure-Related Major Adverse Events (MAE)

  30 days, 9 months

• Technical Success

  Day of Procedure

• Acute Procedural Success

  Day of Procedure, prior to hospital discharge

• Target Lesion Revascularization (TLR)

  9 months

• Rate of Incidental TLR

  9 months

Study Arms (1)

iCAST RX™ Stent Systen

EXPERIMENTAL

All enrolled subjects will receive the iCAST RX™ Stent System

Device: iCAST™ Rx Stent System

Interventions

iCAST™ Rx Stent System DEVICE

All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.

Also known as: iCAST™ RX

iCAST RX™ Stent Systen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (12)

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756, United States

Location

Advocate Health and Hospitals Corporation

Naperville, Illinois, 60563, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beaumont Health Systems

Royal Oak, Michigan, 48073, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Mid Carolina Cardiology

Charlotte, North Carolina, 28204, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27610, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

MeSH Terms

Conditions

Renal Artery Obstruction; Hypertension, Renovascular; Hypertension

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension, Renal

Limitations and Caveats

The limitation of the study was the termination of enrollment due to the change in clinical practice.

Results Point of Contact

• Title: Sr. Clinical Trial Manager
• Organization: Getinge

inka.vesela@getinge.com

603-864-5219

Study Officials

• Ken Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Gary Ansel, MD

  OhioHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: October 23, 2012
• Primary Completion: June 27, 2018
• Study Completion: October 26, 2020
• Last Updated: November 20, 2020
• Results First Posted: August 13, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)