Renal Artery StenosisNCT00631540
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
A study testing Formula Balloon-Expandable Stent in people with Renal Artery Stenosis, run by Cook Group Incorporated at 7 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- Formula Balloon-Expandable Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2008to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- renal artery stenosis
- appropriate size and location of the lesion
- suboptimal angioplasty
Who cannot join
- less than 18 years old
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, 17110
Fairfield Medical Center
Lancaster, Ohio, 43130
Lenox Hill Hospital
New York, New York, 10075
Munroe Regional Medical Center
Ocala, Florida, 34471
Orlando Regional Medical Center
Orlando, Florida, 32806
Wake Med Raleigh Campus
Raleigh, North Carolina, 27610
Swedish Medical Center
Seattle, Washington, 98122
About this study
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
- Conditions
- Renal Artery Stenosis
- Being tested
- Formula Balloon-Expandable Stent
- Keywords
- renal artery stenosis, hypertension, renovascular, renal artery blockage, renal artery disease, renal arteries, angioplasty renal artery, renal artery stent, renal artery doppler, renovascular hypertension, kidney stenosis, renal artery, stent, stenting, kidney disease, renal failure, atherosclerosis, arterial hypertension, stenosis
- Medical subject headings
- Renal Artery Obstruction, Hypertension, Hypertension, Renovascular, Kidney Diseases, Renal Insufficiency, Atherosclerosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula Balloon-Expandable StentDevice
Also called renal artery revascularization
renal artery stenting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | renal artery stenting Receives: Device: Formula Balloon-Expandable Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency of the Treated Renal Artery
Based on ultrasound images assessed by core lab.
Measured: 9 Months
Secondary outcomes (5)
Number of Participants With 30-day Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Measured: 30 Days
Number of Participants With 9-month Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Measured: 9 Months
Technical Success
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Measured: Prior to Discharge
Acute Procedural Success
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Measured: Prior to Discharge
30-day Clinical Success
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bersin, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631540
- Sponsor's protocol ID
- 06-581
- Other IDs
- FRUS
- Status last verified
- Nov 2013
- First submitted
- 28 Feb 2008
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
PubMed 22581488
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
- ClinicalTrials.gov ID
- NCT00631540
- Acronym / sponsor ID
- 06-581
- Conditions
- Renal Artery Stenosis
- Keywords
- renal artery stenosis, hypertension, renovascular, renal artery blockage, renal artery disease, renal arteries, angioplasty renal artery, renal artery stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 19 May 2011
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 the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
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: Formula Balloon-Expandable Stentrenal artery stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal artery stenosis
- appropriate size and location of the lesion
- suboptimal angioplasty
Key exclusion criteria (3 listed)
- less than 18 years old
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
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 |
|---|---|---|
| Formula Balloon-Expandable StentAlso: renal artery revascularizationrenal artery stenting | Device | 1 |
Primary outcome
Primary Patency of the Treated Renal Artery
Time frame: 9 Months
Based on ultrasound images assessed by core lab.
5 secondary outcomes
Number of Participants With 30-day Major Adverse Events
Time frame: 30 Days
Number of Participants With 9-month Major Adverse Events
Time frame: 9 Months
Technical Success
Time frame: Prior to Discharge
Acute Procedural Success
Time frame: Prior to Discharge
30-day Clinical Success
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22581488Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
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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.
Robert Bersin, MD principal investigator
Swedish Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula Balloon-Expandable Stent in people with Renal Artery Stenosis, run by Cook Group Incorporated at 7 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 3 inclusion and 3 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Patency of the Treated Renal Artery (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 NCT00631540, 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 16 Dec 2013.