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To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PAD | Experimental | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jetstream Atherectomy System | Device | to perform atherectomy on calcified lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Luminal Area Change | lumen area change as measured by intravascular ultrasound (IVUS) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjunctive Therapy Use | Day 0 | |
| Residual Diameter Stenosis | lumen diameter stenosis change post-atherectomy | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
Patient is unable to take appropriate anti-platelet therapy.
Patient has no distal runoff vessels.
Deep wall calcium.
Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or tortuosity at the treatment segment.
Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
Patient is receiving hemodialysis or has impaired renal function (creatinine is > 2.5 mg/dl) at the time of treatment.
Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
Patient is pregnant or nursing a child.
Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.
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| Name | Affiliation | Role |
|---|---|---|
| Tom Davis, MD | St. John Hospital | Principal Investigator |
| Malcolm Foster | Mercy Medical Center | Principal Investigator |
| Venkatesh Ramaiah, MD | Arizona Heart Institute | Principal Investigator |
| Joseph Ricotta, MD | Emory University | Principal Investigator |
| Thomas Shimshak, MD | Wheaton Franciscan Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Institute | Phoenix | Arizona | 85006 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28504047 | Derived | Yin D, Maehara A, Shimshak TM, Ricotta JJ 2nd, Ramaiah V, Foster MT 3rd, Davis TP, Matsumura M, Mintz GS, Gray WA. Intravascular Ultrasound Validation of Contemporary Angiographic Scores Evaluating the Severity of Calcification in Peripheral Arteries. J Endovasc Ther. 2017 Aug;24(4):478-487. doi: 10.1177/1526602817708796. Epub 2017 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | subjects with calcified peripheral arterial lesions determined by intravascular ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | subjects with calcified peripheral arterial lesions determined by intravascular ultrasound |
| 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 | Luminal Area Change | lumen area change as measured by intravascular ultrasound (IVUS) | Posted | Mean | Standard Deviation | mm^2 | Day 0 |
|
|
through 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 | Study Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanna Kennedy | Boston Scientific | 763.494.2601 | susanna.kennedy@bsci.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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| Atlanta |
| Georgia |
| 30322 |
| United States |
| St. John Hopital | Detroit | Michigan | 48236 | United States |
| Mercy Medical Center | Knoxville | Tennessee | 37934 | United States |
| Wheaton Franciscan Healthcare | Milwaukee | Wisconsin | 53210 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Adjunctive Therapy Use | Posted | Number | percentage of participants | Day 0 |
|
|
|
| Secondary | Residual Diameter Stenosis | lumen diameter stenosis change post-atherectomy | Posted | Mean | Standard Deviation | percentage change | Day 0 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Unplanned amputation | Surgical and medical procedures | Non-systematic Assessment |
|
| Target lesion revascularization | Surgical and medical procedures | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |