With de Novo or Restenotic Lesions in the Common and/or External Iliac ArteriesI-WINNCT00613418
Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery
A study testing IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System in people with With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries, run by Abbott Medical Devices.
Trial summary
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries
- What is being tested?
- IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System
- 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
- 1 Jan 2019to 1 Jan 2019
- 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 is 18 years of age or older and of legal age of consent.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
- Subject has de novo or restenotic lesions in the common or external iliac artery.
- Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
- The target segment of subject's lesion(s) is between 4 and 10 mm in diameter and less than 110 mm in length.
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- Subject has angiographic evidence of a patent femoral outflow artery in the target limb.
- Subject has provided written informed consent.
- Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
- Subject is able and willing to adhere to the required follow-up medication regimen
- -
Who cannot join
- Presence of other non-target arterial lesions requiring treatment within 30 days of the procedure.
- The target lesion(s) has adjacent, acute thrombus.
- The target lesion(s) is highly calcified or was previously treated with a stent.
- Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
- Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. Subject has a pre-existing aneurysm or dissection of the target iliac segment.
- Subject with aortic or iliac aneurysm that is likely to require repair within the next 9 months.
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- Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
- Subject has a vascular graft previously implanted in the native iliac vessel.
- Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
- Subject is unable to accommodate ≥ 7 Fr cat
- Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to nickel, or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- Subject has history of neutropenia (WBC <3,000/mm3).
- Subject has coagulopathy or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
- Subject has known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected.
- Subject has the following laboratory values:
- international normalized ratio (INR) greater than 1.5,
- serum creatinine level greater than 2.5 mg/dL.
- Subject requires general anesthesia for the procedure.
- Subject is pregnant or plans to become pregnant during the study.
- Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
- -
About this study
Official title: Comparative Study of Safety and Efficacy of the SUPERA® Wire Interwoven Self-expanding Nitinol Stent and Currently Approved Stents for Patients With Iliac Lesions
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in the common and/or external iliac arteries.
- Being tested
- IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular SystemDevice
Interwoven, self-expanding nitinol stent system, including delivery system and stent
| Study group | Role | What they receive |
|---|---|---|
| single | Other | Historical control Receives: Device: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of death
Measured: within 30 days post-procedure
Target site revascularization or restenosis
Measured: 9 months
Secondary outcomes (6)
Major adverse events (MAEs)
Measured: 30 days
Device success (delivery and deployment of the study stent and retrieval of the delivery system)
Measured: During implantation procedure
Acute procedural success
Measured: immediately following stent deployment
Early and late clinical success (Rutherford-Becker improvement); ABI and TBI improvement; symptom based.
Measured: 30 days and 6, 9, and 12 months
Target vessel patency
Measured: 6, 9, 12, 24, and 36 months
Quality of Life questionnaire
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Why it stopped: study did not move forward due to change in clinical strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for With de Novo or Restenotic Lesions in the Common and/or External Iliac ArteriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613418
- Sponsor's protocol ID
- I-1 - US
- Acronym
- I-WIN
- Status last verified
- May 2019
- First submitted
- 30 Jan 2008
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Safety and Efficacy of the SUPERA® Wire Interwoven Self-expanding Nitinol Stent and Currently Approved Stents for Patients With Iliac Lesions
- ClinicalTrials.gov ID
- NCT00613418
- Acronym / sponsor ID
- I-WIN / I-1 - US
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study did not move forward due to change in clinical strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 13 Feb 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.
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in the common and/or external iliac arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | Other | Device: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular SystemHistorical control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is 18 years of age or older and of legal age of consent.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
- Subject has de novo or restenotic lesions in the common or external iliac artery.
- Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
Key exclusion criteria (22 listed)
- Presence of other non-target arterial lesions requiring treatment within 30 days of the procedure.
- The target lesion(s) has adjacent, acute thrombus.
- The target lesion(s) is highly calcified or was previously treated with a stent.
- Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
- Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. Subject has a pre-existing aneurysm or dissection of the target iliac segment.
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® Interwoven Self Expanding Nitinol Stent Peripheral Vascular SystemInterwoven, self-expanding nitinol stent system, including delivery system and stent | Device | single |
Primary outcome
Occurrence of death
Time frame: within 30 days post-procedure
Target site revascularization or restenosis
Time frame: 9 months
6 secondary outcomes
Major adverse events (MAEs)
Time frame: 30 days
Device success (delivery and deployment of the study stent and retrieval of the delivery system)
Time frame: During implantation procedure
Acute procedural success
Time frame: immediately following stent deployment
Early and late clinical success (Rutherford-Becker improvement); ABI and TBI improvement; symptom based.
Time frame: 30 days and 6, 9, and 12 months
Target vessel patency
Time frame: 6, 9, 12, 24, and 36 months
Quality of Life questionnaire
Time frame: baseline, 3 and 6 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 9 May 2019.
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® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System in people with With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries, 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 11 inclusion and 22 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 9 May 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?
Occurrence of death (time frame: within 30 days post-procedure). The study lists 2 primary outcomes in all. 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 9 May 2019.