Stenosis of ArteryNCT03994185
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
A study testing Placement of WRAPSODY stent graft in people with Stenosis of Artery and Peripheral Arterial Disease, run by Merit Medical Systems, Inc..
Trial summary
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stenosis of Artery, Peripheral Arterial Disease, Iliac Artery Disease
- What is being tested?
- Placement of WRAPSODY stent graft
- 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
- Sep 2020to 31 Dec 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed informed consent
- Subject is ≥ 21 years of age
- Subject is able and willing to comply with study requirements
- Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
- Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
- Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in the common and/or external iliac artery(ies) (multiple stenoses may exist within the target lesion)
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- Total lesion(s) length is ≤ 110mm
- Target lesion(s) is at least 3 cm from an existing stent or stent graft
- At least 1 stenosis in the target vessel has ≥ 50% stenosis
- Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement
- Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic) superficial femoral or profundal femoral artery
- Full expansion of an appropriately sized (in the investigator's opinion) standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment
Who cannot join
- Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure
- Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
- Previous or planned bypass surgery in the target limb(s)
- Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
- Subject has had a stroke within 90 days prior to the index study procedure
- Subject has had a transient ischemic attack within 30 days prior to the index study procedure
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- Uncorrectable coagulation disorder
- Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator
- Condition unrelated to study anticipated to require indefinite anticoagulation
- Evidence of blood borne infection
- Hypersensitivity to nickel titanium alloy
- Allergy to radiographic contrast material which cannot be adequately premedicated
- Serum creatinine >2.5mg/dL
- The subject is enrolled in another investigational study
- Life expectancy is ≤ 12 months
- Active malignancy other than non-melanomatous skin cancer
- Stenosis/restenosis is located within a previously placed stent or stent graft
- Angiographic evidence of thrombus within or adjacent to the target lesion(s)
- Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device
- Abdominal aortic artery stent, if it could interfere with placement of the study device
- Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent
- Lesions requiring atherectomy or ablation to facilitate stent graft delivery
- Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject
About this study
Official title: Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
Read the detailed description
Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically necessary,
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure. The primary clinical effectiveness endpoint is the proportion of subjects with a composite improvement of at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after index procedure.
- Conditions
- Stenosis of Artery, Peripheral Arterial Disease, Iliac Artery Disease, Iliac Artery Occlusion
- Being tested
- Placement of WRAPSODY stent graft
- Keywords
- PAOD, Peripheral Arterial Occlusive Disease, Iliac Artery Disease, Stent Graft
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of WRAPSODY stent graftDevice
Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
| Study group | Role | What they receive |
|---|---|---|
| Group Treated with stent graft | Experimental | This is a single arm study. All subjects will be treated with the WRAPSODY stent graft. Receives: Device: Placement of WRAPSODY stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint of subjects free from specified adverse events
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure.
Measured: 4 weeks after placement of WRAPSODY stent graft
Effectiveness endpoint of subjects with improvement of Rutherford Category
The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category within 4 weeks of the index procedure. Composite with Outcome 3.
Measured: 4 weeks after placement of WRAPSODY stent graft
Effectiveness endpoint of subjects with patency
The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure. Composite with Outcome 2.
Measured: 4 weeks after placement of WRAPSODY stent graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study startSep 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Study was withdrawn by the Sponsor prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of ArteryStudies 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
- Model description
- Approximately 30 subjects will be enrolled and treated with the study device
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994185
- Sponsor's protocol ID
- IOD-P2-19-01
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
- ClinicalTrials.gov ID
- NCT03994185
- Acronym / sponsor ID
- IOD-P2-19-01
- Conditions
- Stenosis of Artery, Peripheral Arterial Disease, Iliac Artery Disease, Iliac Artery Occlusion
- Keywords
- PAOD, Peripheral Arterial Occlusive Disease, Iliac Artery Disease, Stent Graft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn by the Sponsor prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Jun 2019 (actual)
- 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, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
Detailed description
Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically necessary,
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure. The primary clinical effectiveness endpoint is the proportion of subjects with a composite improvement of at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 30 subjects will be enrolled and treated with the study device
| Arm | Type | Receives |
|---|---|---|
| Group Treated with stent graft | Experimental | Device: Placement of WRAPSODY stent graftThis is a single arm study. All subjects will be treated with the WRAPSODY stent graft. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has signed informed consent
- Subject is ≥ 21 years of age
- Subject is able and willing to comply with study requirements
- Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
- Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
Key exclusion criteria (23 listed)
- Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure
- Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
- Previous or planned bypass surgery in the target limb(s)
- Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
- Subject has had a stroke within 90 days prior to the index study 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 |
|---|---|---|
| Placement of WRAPSODY stent graftPlacement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation. | Device | Group Treated with stent graft |
Primary outcome
Safety endpoint of subjects free from specified adverse events
Time frame: 4 weeks after placement of WRAPSODY stent graft
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure.
Effectiveness endpoint of subjects with improvement of Rutherford Category
Time frame: 4 weeks after placement of WRAPSODY stent graft
The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category within 4 weeks of the index procedure. Composite with Outcome 3.
Effectiveness endpoint of subjects with patency
Time frame: 4 weeks after placement of WRAPSODY stent graft
The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure. Composite with Outcome 2.
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 24 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Andrew Holden principal investigator
Auckland City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Placement of WRAPSODY stent graft in people with Stenosis of Artery and Peripheral Arterial Disease, run by Merit Medical Systems, Inc..
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 12 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: withdrawn, as of the sponsor's last update on 24 Apr 2020. 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?
Safety endpoint of subjects free from specified adverse events (time frame: 4 weeks after placement of WRAPSODY stent graft). The study lists 3 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 24 Apr 2020.