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This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longer Stents | Experimental |
| |
| Shorter Stents | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Longer Zilver PTX Stents | Device | Treatment with at least one 100 mm or longer Zilver PTX stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Stent Length Upon Deployment | During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. med. Jens Ricke | Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz-Zentrum | Bad Krozingen | 79189 | Germany | |||
| Evangelische Krankenhaus Königin Elisabeth Herzberge |
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| ID | Title | Description |
|---|---|---|
| FG000 | Longer Stents | Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent |
| FG001 | Shorter Stents | Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Longer Stents | Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent |
| BG001 | Shorter Stents | Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only |
| 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 | Percent Change in Stent Length Upon Deployment | Posted | Mean | Standard Deviation | Change in stent length (%) | During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) |
|
|
30 days
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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 | Stented Patients | The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal disease | Renal and urinary disorders | Systematic Assessment | failed hemodialysis shunt requiring revision (Due to a pre-existing condition.) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, PhD, Director of Clinical Science and Biostatistics | Cook | 765-463-7537 | ssnyder@medinst.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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| Shorter Zilver PTX Stents | Device | Treatment with Zilver PTX stents 80 mm or shorter only |
|
| Berlin |
| 10365 |
| Germany |
| Universitätsklinikum Magdeburg A.ö.R. | Magdeburg | 39120 | Germany |
| INSELSPITAL, Universitätsspital Bern | Bern | 3010 | Switzerland |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| 5 |
| 45 |
| 0 |
| 45 |
|
| Pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | exacerbation of COPD (Due to a pre-existing condition.) |
|
| Orthopedic/vascular repair | Surgical and medical procedures | Systematic Assessment | lumbar protrusion (Due to other medical problems.) |
|
| Restenosis/occlusion of study lesion | Vascular disorders | Systematic Assessment |
|
| Restenosis/occlusion of non-study limb | Vascular disorders | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |