Atherosclerotic Lesions in the Aortorenal OstiumPhase 4RENAISSANCENCT00597142
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
A Phase 4 study testing Express™ Renal Premounted Stent System in people with Atherosclerotic Lesions in the Aortorenal Ostium, run by Boston Scientific Corporation at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Lesions in the Aortorenal Ostium
- What is being tested?
- Express™ Renal Premounted Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2004to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
CAMC Institute
Charleston, West Virginia, 25304
Greenville Hospital System
Greenville, South Carolina, 29605
St. Luke's Episcopal Hospital
Houston, Texas, 77030
St. Vincent Hospital & Health Care Center, Inc.
Indianapolis, Indiana, 46260
The Care Group, LLC
Indianapolis, Indiana, 46260
Cardiovascular Institute of the South (CIS)
Lafayette, Louisiana, 70506
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
NYPH & Trustees of Columbia University of New York
New York, New York, 10032
Peoria Radiology Associates Research & Education Foundation
Peoria, Illinois, 61637
Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
WakeMed
Raleigh, North Carolina, 27610
Sarasota Memorial Hospital Care System
Sarasota, Florida, 34239
North Central Heart Institute
Sioux Falls, South Dakota, 57108
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
About this study
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.
- Being tested
- Express™ Renal Premounted Stent System
- Keywords
- renal stent, stent, atherosclerosis, aortorenal ostium, renal, renal artery, PTRA
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Express™ Renal Premounted Stent SystemDevice
This device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a:
- Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery
- Lesion length ≤15mm
- Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
- RVD 4.0-7.0mm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Express™ Renal Premounted Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
Measured: 9 months
Secondary outcomes (8)
Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.
Measured: Post stent deployment
Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.
Measured: 9 months
Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.
Measured: 9 Months
Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups
Measured: 9 months
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.
Measured: 9 Months
Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups
Measured: 9 Months
Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure
Measured: 9 Months
Technical success as visually assessed by the investigator.
Measured: Immediately after stent deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionJul 2005
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Lesions in the Aortorenal OstiumStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Grady, PhD, Study director, Boston Scientific CorporationKrishna Rocha-Singh, MD, Principal investigator, Prairie Cardiovascular Heart Institute, St. John's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597142
- Sponsor's protocol ID
- S2006
- Acronym
- RENAISSANCE
- Status last verified
- Nov 2014
- First submitted
- 9 Jan 2008
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19006254
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00597142
- Acronym / sponsor ID
- RENAISSANCE / S2006
- Keywords
- renal stent, stent, atherosclerosis, aortorenal ostium, renal, renal artery, PTRA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Express™ Renal Premounted Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Express™ Renal Premounted Stent SystemThis device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a: * Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery * Lesion length ≤15mm * Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen * RVD 4.0-7.0mm | Device | 1 |
Primary outcome
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
Time frame: 9 months
8 secondary outcomes
Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.
Time frame: Post stent deployment
Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.
Time frame: 9 months
Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.
Time frame: 9 Months
Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups
Time frame: 9 months
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.
Time frame: 9 Months
Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups
Time frame: 9 Months
Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure
Time frame: 9 Months
Technical success as visually assessed by the investigator.
Time frame: Immediately after stent deployment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Results publication: PubMed 19006254Rocha-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Grady, PhD study director
Boston Scientific Corporation
Krishna Rocha-Singh, MD principal investigator
Prairie Cardiovascular Heart Institute, St. John's Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Express™ Renal Premounted Stent System in people with Atherosclerotic Lesions in the Aortorenal Ostium, run by Boston Scientific Corporation at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.