Peripheral Vascular DiseasePARADIGMNCT01667393
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
A study testing IDEV SUPERA Stent and Percutaneous Transluminal Angioplasty in people with Peripheral Vascular Disease, run by Abbott Medical Devices.
Trial summary
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- IDEV SUPERA Stent and Percutaneous Transluminal Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2013
- 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
- Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.
Who cannot join
- Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.
About this study
Official title: Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.
- Conditions
- Peripheral Vascular Disease
- Being tested
- IDEV SUPERA Stent, Percutaneous Transluminal Angioplasty
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEV SUPERA StentDevice
Percutaneous Transluminal AngioplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| IDEV SUPERA Stent | Experimental | Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment. Receives: Device: IDEV SUPERA Stent |
| Percutaneous Transluminal Angioplasty | Active comparator | The target lesion will be treated by PTA alone. Receives: Device: Percutaneous Transluminal Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary efficacy will be target lesion primary patency at 12 months.
Measured: 12 months
Secondary outcomes (1)
MAE-free survival rate.
Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667393
- Sponsor's protocol ID
- IDEV POP-01-US/OUS
- Acronym
- PARADIGM
- Status last verified
- Apr 2019
- First submitted
- 14 Aug 2012
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System
- ClinicalTrials.gov ID
- NCT01667393
- Acronym / sponsor ID
- PARADIGM / IDEV POP-01-US/OUS
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2013
- Study completion
- Jan 2013
- First posted
- 17 Aug 2012 (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.
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDEV SUPERA Stent | Experimental | Device: IDEV SUPERA StentFollowing PTA of the target lesion, the SUPERA stent will be delivered to the treated segment. |
| Percutaneous Transluminal Angioplasty | Active comparator | Device: Percutaneous Transluminal AngioplastyThe target lesion will be treated by PTA alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.
Key exclusion criteria (1 listed)
- Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.
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 |
|---|---|---|
| IDEV SUPERA Stent | Device | IDEV SUPERA Stent |
| Percutaneous Transluminal Angioplasty | Device | Percutaneous Transluminal Angioplasty |
Primary outcome
Primary patency
Time frame: 12 months
Primary efficacy will be target lesion primary patency at 12 months.
1 secondary outcome
MAE-free survival rate.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IDEV SUPERA Stent and Percutaneous Transluminal Angioplasty in people with Peripheral Vascular Disease, run by Abbott Medical Devices.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 12 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 17 Apr 2019.