Renal Artery StenosisNCT01057316
Formula PTX Renal Stent Clinical Study
A study testing Formula PTX Stent - Dose 1, Formula PTX Stent - Dose 2 and Formula PTX Stent - Dose 3 in people with Renal Artery Stenosis, run by Cook Group Incorporated at 12 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX 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 PTX Stent - Dose 1, Formula PTX Stent - Dose 2 and Formula PTX Stent - Dose 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Feb 2010to 9 Apr 2018
- Phase
- Interventional
- 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
- renal artery stenosis
- appropriate size and location of the lesion
Who cannot join
- pregnant or breast feeding
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany6 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Krankenhaus Neu-Bethlehem
Göttingen, 37073
Uniklinik Heidelberg
Heidelberg
Universitatsklinikum Leipzig AoR
Leipzig, 04103
St. Bonifatius Hospital
Lingen, 49808
Klinik Dr. Hancken im Elbe Klinikum Stade
Stade, 21682
United Kingdom3 sites
Royal Sussex County Hospital
Brighton, BN5BE
Kent & Canterbury Hospital
Canterbury, CT1 3NG
St. Mary's Hospital
London, W2 1NY
Czechia2 sites
University Hospital Ostrava
Ostrava-Poruba, 70852
Institute for Clinical and Experimental Medicine
Prague
About this study
Official title: Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.
- Conditions
- Renal Artery Stenosis
- Being tested
- Formula PTX Stent - Dose 1, Formula PTX Stent - Dose 2, Formula PTX Stent - Dose 3
- Medical subject headings
- Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula PTX Stent - Dose 1Device
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Formula PTX Stent - Dose 2Device
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Formula PTX Stent - Dose 3Device
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
| Study group | Role | What they receive |
|---|---|---|
| Study Group A | Experimental | Not described Receives: Device: Formula PTX Stent - Dose 1 |
| Study Group B | Experimental | Not described Receives: Device: Formula PTX Stent - Dose 2 |
| Study Group C | Experimental | Not described Receives: Device: Formula PTX Stent - Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Diameter Stenosis of the Treated Renal Artery
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2014
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057316
- Sponsor's protocol ID
- 06-008
- Status last verified
- May 2018
- First submitted
- 25 Jan 2010
- Last updated
- 1 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
- ClinicalTrials.gov ID
- NCT01057316
- Acronym / sponsor ID
- 06-008
- Conditions
- Renal Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 27 Jan 2010 (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 the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group A | Experimental | Device: Formula PTX Stent - Dose 1 |
| Study Group B | Experimental | Device: Formula PTX Stent - Dose 2 |
| Study Group C | Experimental | Device: Formula PTX Stent - Dose 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- renal artery stenosis
- appropriate size and location of the lesion
Key exclusion criteria (3 listed)
- pregnant or breast feeding
- 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 PTX Stent - Dose 1Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. | Device | Study Group A |
| Formula PTX Stent - Dose 2Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. | Device | Study Group B |
| Formula PTX Stent - Dose 3Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. | Device | Study Group C |
Primary outcome
Percent Diameter Stenosis of the Treated Renal Artery
Time frame: 9 months
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 1 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula PTX Stent - Dose 1, Formula PTX Stent - Dose 2 and Formula PTX Stent - Dose 3 in people with Renal Artery Stenosis, run by Cook Group Incorporated at 12 sites in 4 countries.
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 2 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, United Kingdom, Czechia, France. 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?
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?
Percent Diameter Stenosis 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?
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 1 Jun 2018.