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The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EverFlex™ stent with Entrust™ delivery system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EverFlex™ stent with Entrust™ delivery system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Stent Elongation | Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length | Intra operative |
| Successful Stent Deployment | Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment. | Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl M Wahlgren, MD/PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Weiden | Weiden | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | EverFlex™ Stent With Entrust™ Delivery System | Subjects were treated with the EverFlex™ stent with Entrust™ delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EverFlex™ Stent With Entrust™ Delivery System | EverFlex™ stent with Entrust™ delivery system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absence of Stent Elongation | Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length | Posted | Number | percentage absence of stent elongation | Intra operative | Number of Stents Implanted | Number of Stents Implanted |
|
|
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Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EverFlex™ Stent With Entrust™ Delivery System | EverFlex™ stent with Entrust™ delivery system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastronintestinal disorders | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763-398-7932 | stephanie.a.cihlar@medtronic.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Stents Implanted |
|
|
| Primary | Successful Stent Deployment | Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment. | Posted | Number | percentage - successful stent deployment | Procedure | Stents Implanted | Stents Implanted |
|
|
|
| 4 |
| 34 |
| 0 |
| 34 |
| General disorders | General disorders |
|
| Infections and infestations | Infections and infestations |
|
| Renal and urinary disorders | Renal and urinary disorders |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders |
|
| Surgical and medical procedures | Surgical and medical procedures |
|
| Vascular disorders | Vascular disorders |
|
There is an agreement between the Principal Investigator and Sponsor [or its agents] that restricts PI's rights to discuss or publish trial results without permission of the Sponsor.
Trial is still ongoing.
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |