Skip to content

Zainidip in Renal Artery Stenosis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02594410
Enrollment
149
Registered
2015-11-03
Start date
2011-09-30
Completion date
2014-05-31
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DEVICEstent

patients receiving renal artery stenting for renal artery atherosclerosis

DRUGAspirine

100mg Qd

DRUGClopidogrel

75mg Qd

10-20mg Qd

Sponsors

Lee's Pharmaceutical Limited
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate12 months
Blood pressure12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026