Zainidip in Renal Artery Stenosis

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Clopidogrel; Lercanidipine

Criteria

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.