CompletedNot Applicable

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

United States68 participantsStarted 2012-10-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).
. 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.

Exclusion criteria

. Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral renal arteries.
. Renal pole-to-pole length \> 8cm (per visual estimate).
. Target lesion length ≤ 16mm per vessel (per visual estimate).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Patency

Timeframe: 9 months

Systolic Blood Pressure

Timeframe: Baseline and 9 months

Trial details

NCT IDNCT01673373

SponsorAtrium Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-27

Results submitted2019-06-27

View on ClinicalTrials.gov More Renal Artery Stenosis trials