NCT00234585

Brief Summary

This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_2

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

August 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

4.8 years

First QC Date

October 5, 2005

Last Update Submit

December 9, 2014

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (2)

  • Glomerular Filtration Rate

  • Adverse Events

Interventions

Renal Artery Stent with Protective Device/DrugDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any one or more of the following:
  • Meet Angiographic criteria plus
  • Systemic hypertension at baseline, or a history of hypertension
  • Congestive heart failure at baseline, or a history of CHF
  • Renal insufficiency at baseline, or a history of renal insufficiency
  • Angina, or a history of angina

You may not qualify if:

  • Less than 18 years old
  • Contraindications to device/drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

Related Publications (6)

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PMID: 35224730DERIVED

  • Yu H, Zhang D, Haller S, Kanjwal K, Colyer W, Brewster P, Steffes M, Shapiro JI, Cooper CJ. Determinants of renal function in patients with renal artery stenosis. Vasc Med. 2011 Oct;16(5):331-8. doi: 10.1177/1358863X11419998. Epub 2011 Sep 9.

    PMID: 21908683DERIVED

  • Tian J, Haller S, Periyasamy S, Brewster P, Zhang H, Adlakha S, Fedorova OV, Xie ZJ, Bagrov AY, Shapiro JI, Cooper CJ. Renal ischemia regulates marinobufagenin release in humans. Hypertension. 2010 Nov;56(5):914-9. doi: 10.1161/HYPERTENSIONAHA.110.155564. Epub 2010 Sep 7.

    PMID: 20823380DERIVED

  • Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW, Steffes M, Brewster P, Zhang H, Colyer WR Jr. Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):16-23. doi: 10.1002/ccd.22469.

    PMID: 20209644DERIVED

  • Kanjwal K, Haller S, Steffes M, Virmani R, Shapiro JI, Burket MW, Cooper CJ, Colyer WR Jr. Complete versus partial distal embolic protection during renal artery stenting. Catheter Cardiovasc Interv. 2009 May 1;73(6):725-30. doi: 10.1002/ccd.21932.

    PMID: 19198007DERIVED

  • Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, Khuder S. Embolic protection and platelet inhibition during renal artery stenting. Circulation. 2008 May 27;117(21):2752-60. doi: 10.1161/CIRCULATIONAHA.107.730259. Epub 2008 May 19.

    PMID: 18490527DERIVED

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher Cooper, M.D.

    Medical University of Ohio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

August 1, 2002

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)