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

Renal Artery Stenosis Clinical Trial

— GREAT  

Official title:

Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235157
• Other study ID #: EE01-01
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2005
• Last updated: August 5, 2008
• Start date: November 2001
• Est. completion date: July 2005

Study information

• Verified date: August 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2005
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Device:
• Sirolimus-eluting Palmaz Genesis peripheral stent
treatment of renal artery stenosis with a renal stent

Locations

Country	Name	City	State
France	Hopital Européen Georges Pompidou	Paris
Germany	Universitätskliniken Köln	Köln
Netherlands	Erasmus MC Rotterdam	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

References & Publications (1)

Zähringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Bérégi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the angiographical in-stent minimal lumen diameter		6-months follow up	Yes
Secondary	clinical primary patency		discharge, 1, 6 and 12 months post-procedure	Yes
Secondary	procedural success		post-procedure	Yes
Secondary	worsening renal function		30 days, 6 months, 12 months	Yes
Secondary	change in blood pressure measurement		30 days, 6 months, 12 months	Yes
Secondary	significant embolic events causing end-organ damage		30 days, 6 months, and 12 months	Yes