PMID- 19635148
OWN - NLM
STAT- MEDLINE
DCOM- 20090918
LR  - 20211020
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 10
DP  - 2009 Jul 27
TI  - RADAR - A randomised, multi-centre, prospective study comparing best medical 
      treatment versus best medical treatment plus renal artery stenting in patients 
      with haemodynamically relevant atherosclerotic renal artery stenosis.
PG  - 60
LID - 10.1186/1745-6215-10-60 [doi]
AB  - BACKGROUND: Prospective, international, multi-centre, randomised (1:1) trial to 
      evaluate the clinical impact of percutaneous transluminal renal artery stenting 
      (PTRAS) on the impaired renal function measured by the estimated glomerular 
      filtration rate (eGFR) in patients with haemodynamically significant 
      atherosclerotic renal artery stenosis. METHODS: Patients will be randomised to 
      receive either PTRAS using the Dynamic Renal Stent system plus best medical 
      treatment or best medical treatment. Renal stenting will be performed under 
      angiographic imaging. For patients randomised to best medical treatment the 
      degree of stenosis measured by renal duplex sonography (RDS) will be confirmed by 
      MR angio or multi-slice CT where possible. Best medical treatment will be 
      initiated at randomisation or post procedure (for PTRAS arm only), and adjusted 
      as needed at all visits. Best medical treatment is defined as optimal drug 
      therapy for control of the major risk factors (blood pressure < or = 125/80 mmHg, 
      LDL cholesterol < or = 100 mg/dL, HbA1c < or = 6.5%). Data recordings include 
      serum creatinine values, eGFR, brain natriuretic peptide, patients' medical 
      history and concomitant medication, clinical events, quality of life 
      questionnaire (SF-12v2), 24 hour ambulatory blood pressure measurement, renal 
      artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 
      12 and 36 months following randomisation.The primary endpoint is the difference 
      between treatments in change of eGFR over 12 months. Major secondary endpoints 
      are technical success, change of renal function based on the eGFR slope change 
      between pre-treatment and post-treatment (i.e. improvement, stabilisation, 
      failure), clinical events overall such as renal or cardiac death, stroke, 
      myocardial infarction, hospitalisation for congestive heart failure, progressive 
      renal insufficiency (i.e. need for dialysis), need of target vessel 
      revascularisation or target lesion revascularisation, change in average systolic 
      and diastolic blood pressure, change in left ventricular mass index calculated 
      from echocardiography, difference in the size of kidney (pole to pole length) 
      measured by renal duplex sonography, total number, drug name, drug class, daily 
      dose, regimen and Defined Daily Dose (DDD), of anti-hypertensive drugs, and 
      change in New York Heart Association (NYHA) classification. Approximately 30 
      centres in Europe and South America will enrol patients. Duration of enrolment is 
      expected to be 12 months resulting in study duration of 48 months. TRIAL 
      REGISTRATION NUMBER: NCT00640406.
FAU - Schwarzwalder, Uwe
AU  - Schwarzwalder U
AD  - Department Angiology, Herz-Zentrum Bad Krozingen, Sudring 15, 79189 Bad 
      Krozingen, Germany. uwe.schwarzwaelder@herzzentrum.de
FAU - Hauk, Michael
AU  - Hauk M
FAU - Zeller, Thomas
AU  - Zeller T
LA  - eng
SI  - ClinicalTrials.gov/NCT00640406
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090727
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - *Angioplasty
MH  - Atherosclerosis/surgery/therapy
MH  - Combined Modality Therapy
MH  - Humans
MH  - Prospective Studies
MH  - Renal Artery Obstruction/*surgery/*therapy
MH  - Renal Circulation
MH  - Research Design
MH  - *Stents
PMC - PMC2724429
EDAT- 2009/07/29 09:00
MHDA- 2009/09/19 06:00
PMCR- 2009/07/27
CRDT- 2009/07/29 09:00
PHST- 2009/04/23 00:00 [received]
PHST- 2009/07/27 00:00 [accepted]
PHST- 2009/07/29 09:00 [entrez]
PHST- 2009/07/29 09:00 [pubmed]
PHST- 2009/09/19 06:00 [medline]
PHST- 2009/07/27 00:00 [pmc-release]
AID - 1745-6215-10-60 [pii]
AID - 10.1186/1745-6215-10-60 [doi]
PST - epublish
SO  - Trials. 2009 Jul 27;10:60. doi: 10.1186/1745-6215-10-60.