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OpenTrials
Completed

NCT Number: NCT02594410

Zainidip in Renal Artery Stenosis

To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fuwai Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 40 - 75
  • Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
  • Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
  • length of ipsilateral kidney is greater than 7.0cm.

Exclusion criteria

  • Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
  • unstable condition and unable to tolerate interventional therapy;
  • anatomy of renal artery pathology not suitable for interventional therapy;
  • allergic to dihydropyridines;
  • III degree atrioventricular block
  • contrast allergy ;
  • any known malignant tumor;
  • non-compliant, history of alcoholism or drug abuse.

Treatment and study plan

stent

Device

patients receiving renal artery stenting for renal artery atherosclerosis

Aspirine

Drug

100mg Qd

clopidogrel

Drug

75mg Qd

Lercanidipine

Drug

10-20mg Qd

Primary outcomes

  1. Glomerular filtration rate

    Time frame: 12 months

  2. Blood pressure

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Registry information

Official study title

The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 3, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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