Renal Artery Stenosis
Conditions
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.
Interventions
DEVICESirolimus-eluting Palmaz Genesis peripheral stent
treatment of renal artery stenosis with a renal stent
Sponsors
Cordis US Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assessment of the angiographical in-stent minimal lumen diameter | 6-months follow up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Germany, Netherlands
Outcome results
None listed