NCT02594410

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2011

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

October 29, 2015

Last Update Submit

October 30, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Glomerular filtration rate

    12 months

  • Blood pressure

    12 months

Study Arms (1)

Treatment

EXPERIMENTAL

patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis

Device: stentDrug: AspirineDrug: ClopidogrelDrug: Lercanidipine

Interventions

stentDEVICE

patients receiving renal artery stenting for renal artery atherosclerosis

Treatment
AspirineDRUG

100mg Qd

Treatment
ClopidogrelDRUG

75mg Qd

Treatment
LercanidipineDRUG

10-20mg Qd

Treatment

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

StentsClopidogrellercanidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

CN(1)