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A Comparison of Coated and Uncoated Stents in Renal Artery Treatment. (GREAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235157
First Posted: October 10, 2005
Last Update Posted: August 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  Purpose
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.

Condition Intervention Phase
Renal Artery Stenosis Device: Sirolimus-eluting Palmaz Genesis peripheral stent Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • assessment of the angiographical in-stent minimal lumen diameter [ Time Frame: 6-months follow up ]

Secondary Outcome Measures:
  • clinical primary patency [ Time Frame: discharge, 1, 6 and 12 months post-procedure ]
  • procedural success [ Time Frame: post-procedure ]
  • worsening renal function [ Time Frame: 30 days, 6 months, 12 months ]
  • change in blood pressure measurement [ Time Frame: 30 days, 6 months, 12 months ]
  • significant embolic events causing end-organ damage [ Time Frame: 30 days, 6 months, and 12 months ]

Enrollment: 105
Study Start Date: November 2001
Study Completion Date: July 2005
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sirolimus-eluting Palmaz Genesis peripheral stent
Device: Sirolimus-eluting Palmaz Genesis peripheral stent
treatment of renal artery stenosis with a renal stent
Other Name: Palmaz Genesis Stent

Detailed Description:

Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of >= 50% stenosis and reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.

It is anticipated that the total length of time required to complete the study will be 46 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
  3. The patient must have a baseline serum creatinine of <= 5.0 mg/dl.

Exclusion Criteria:

  1. Total occlusion of the renal artery.
  2. Lesions which would require more than 2 stents.
  3. Lesions which are in arteries to transplanted or bypassed kidneys.
  4. Abdominal aortic aneurysm > 4.0 cm in diameter.
  5. Patients with ASA classification >=4.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235157


Locations
France
Hopital Européen Georges Pompidou
Paris, France, 75 015
Germany
Universitätskliniken Köln
Köln, Germany, 50931
Netherlands
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Markus Zähringer, MD Universitätskliniken Köln
Principal Investigator: Marc Sapoval, MD Hopital Européen Georges Pompidou
Principal Investigator: Peter M Pattynama, MD Erasmus MC Rotterdam
  More Information

Publications:
Responsible Party: Dr. Hans-Peter Stoll, Director Clinical Affairs, Cordis
ClinicalTrials.gov Identifier: NCT00235157     History of Changes
Other Study ID Numbers: EE01-01
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: August 6, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Everolimus
Triamcinolone
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists