Condition or disease | Intervention/treatment | Phase |
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Stenosis of Artery Peripheral Arterial Disease Iliac Artery Disease Iliac Artery Occlusion | Device: Placement of WRAPSODY stent graft | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Approximately 30 subjects will be enrolled and treated with the study device |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease |
Estimated Study Start Date : | September 2020 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Group Treated with stent graft
This is a single arm study. All subjects will be treated with the WRAPSODY stent graft.
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Device: Placement of WRAPSODY stent graft
Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Andrew Holden | Auckland City Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 19, 2019 | ||||||||
First Posted Date ICMJE | June 21, 2019 | ||||||||
Last Update Posted Date | April 24, 2020 | ||||||||
Estimated Study Start Date ICMJE | September 2020 | ||||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease | ||||||||
Official Title ICMJE | Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease | ||||||||
Brief 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 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Approximately 30 subjects will be enrolled and treated with the study device Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Placement of WRAPSODY stent graft
Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
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Study Arms ICMJE | Experimental: Group Treated with stent graft
This is a single arm study. All subjects will be treated with the WRAPSODY stent graft.
Intervention: Device: Placement of WRAPSODY stent graft
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Withdrawn | ||||||||
Actual Enrollment ICMJE |
0 | ||||||||
Original Estimated Enrollment ICMJE |
30 | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03994185 | ||||||||
Other Study ID Numbers ICMJE | IOD-P2-19-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Merit Medical Systems, Inc. | ||||||||
Study Sponsor ICMJE | Merit Medical Systems, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Merit Medical Systems, Inc. | ||||||||
Verification Date | April 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |