Clinical trial NCT00597142: A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
Official title: A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerotic Lesions in the Aortorenal Ostium
Keywords: renal stent
stent
atherosclerosis
aortorenal ostium
renal
renal artery
PTRA
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.


Eligibility criteria: Inclusion Criteria:

* Eligible for PTRA and stenting.
* One or more of the following: (1-3)
* Hypertension
* Recurrent "flash" pulmonary edema out of proportion to any impairment of left ventricular function
* Renal Dysfunction
* Single, de novo, or restenotic (from prior PTRA) atherosclerotic lesion in the ostium of the renal artery
* Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
* Renal Artery Stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney

Exclusion Criteria:

* Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure
* Advanced renal disease: serum creatinine \> 3.0 mg/dl
* End stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis
* Recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.)
* Documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable)
* Documented allergy to heparin, acetylsalicylic acid (ASA) or clopidogrel
* NYHA Class IV
* Bleeding diathesis
* Thrombocytopenia (platelets \< 100,000/mm3)
* Renal atrophy (renal length ≤ 8 cm determined by renal ultrasound)
* Patients requiring immunosuppressive therapy
* Renal allograft
* Stenosis location in a vascular graft or in a transplant artery Angiographic Exclusion
* Total occlusions
* Thrombus containing lesion
* Prior treatment of target lesion with stent (in-stent restenosis)
* More than one (1) lesion in target vessel
* Non-atherosclerotic stenosis (fibromuscular dysplasia)
* Excessive vessel tortuosity
* Lesion involving a side-branch
* Lesion in accessory renal artery
* Abdominal aortic aneurysm \> 3.5 cm
* Perforated vessels evidenced by extravasation of contrast media

Primary outcomes:
measure: Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
timeFrame: 9 months
Secondary outcomes:
measure: Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.
timeFrame: Post stent deployment
measure: Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.
timeFrame: 9 months
measure: Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.
timeFrame: 9 Months
measure: Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups
timeFrame: 9 months
measure: Change in Renal to Aortic Ratio, Resistive Index, and Peak Systolic Velocity using Ultrasound Core Lab values from pre-procedure to postprocedure and 9-months post-procedure.
timeFrame: 9 Months
measure: Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups
timeFrame: 9 Months
measure: Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure
timeFrame: 9 Months
measure: Technical success as visually assessed by the investigator.
timeFrame: Immediately after stent deployment
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital Care System
state: Florida
city: Peoria
country: United States
facility: Peoria Radiology Associates Research & Education Foundation
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Center, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South (CIS)
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New York
country: United States
facility: NYPH & Trustees of Columbia University of New York
state: New York
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Philadelphia
country: United States
facility: Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Charleston
country: United States
facility: CAMC Institute
state: West Virginia
Study officials:
affiliation: Boston Scientific Corporation
name: Pamela Grady, PhD
role: STUDY_DIRECTOR
affiliation: Prairie Cardiovascular Heart Institute, St. John's Hospital
name: Krishna Rocha-Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rocha-Singh K, Jaff MR, Lynne Kelley E; RENAISSANCE Trial Investigators. Renal artery stenting with noninvasive duplex ultrasound follow-up: 3-year results from the RENAISSANCE renal stent trial. Catheter Cardiovasc Interv. 2008 Nov 15;72(6):853-62. doi: 10.1002/ccd.21749.