Clinical trial NCT00235157: A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.
Official title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Artery Stenosis
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: assessment of the angiographical in-stent minimal lumen diameter
timeFrame: 6-months follow up
Secondary outcomes:
measure: clinical primary patency
timeFrame: discharge, 1, 6 and 12 months post-procedure
measure: procedural success
timeFrame: post-procedure
measure: worsening renal function
timeFrame: 30 days, 6 months, 12 months
measure: change in blood pressure measurement
timeFrame: 30 days, 6 months, 12 months
measure: significant embolic events causing end-organ damage
timeFrame: 30 days, 6 months, and 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Köln
country: Germany
facility: Universitätskliniken Köln
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
Study officials:
affiliation: Universitätskliniken Köln
name: Markus Zähringer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Européen Georges Pompidou
name: Marc Sapoval, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC Rotterdam
name: Peter M Pattynama, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.