NCT00235157

Brief Summary

The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2001

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

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

November 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

October 6, 2005

Last Update Submit

August 5, 2008

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • assessment of the angiographical in-stent minimal lumen diameter

    6-months follow up

Secondary Outcomes (5)

  • clinical primary patency

    discharge, 1, 6 and 12 months post-procedure

  • procedural success

    post-procedure

  • worsening renal function

    30 days, 6 months, 12 months

  • change in blood pressure measurement

    30 days, 6 months, 12 months

  • significant embolic events causing end-organ damage

    30 days, 6 months, and 12 months

Study Arms (1)

1

EXPERIMENTAL

Sirolimus-eluting Palmaz Genesis peripheral stent

Device: Sirolimus-eluting Palmaz Genesis peripheral stent

Interventions

Sirolimus-eluting Palmaz Genesis peripheral stentDEVICE

treatment of renal artery stenosis with a renal stent

Also known as: Palmaz Genesis Stent
1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis \>=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
  • The reference vessel renal artery must be \>= 4mm and \<= 8 mm by visual estimate.
  • The patient must have a baseline serum creatinine of \<= 5.0 mg/dl.

You may not qualify if:

  • Total occlusion of the renal artery.
  • Lesions which would require more than 2 stents.
  • Lesions which are in arteries to transplanted or bypassed kidneys.
  • Abdominal aortic aneurysm \> 4.0 cm in diameter.
  • Patients with ASA classification \>=4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Européen Georges Pompidou

Paris, 75 015, France

Location

Universitätskliniken Köln

Cologne, 50931, Germany

Location

Erasmus MC Rotterdam

Rotterdam, 3000 CA, Netherlands

Location

Related Publications (1)

  • Zahringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Beregi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8. doi: 10.1177/152660280701400405.

    PMID: 17696619RESULT

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

  • Markus Zähringer, MD

    Universitätskliniken Köln

    PRINCIPAL INVESTIGATOR

  • Marc Sapoval, MD

    Hopital Européen Georges Pompidou

    PRINCIPAL INVESTIGATOR

  • Peter M Pattynama, MD

    Erasmus MC Rotterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

November 1, 2001

Primary Completion

November 1, 2002

Study Completion

July 1, 2005

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

DE(1)FR(1)NL(1)