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The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jetstream Atherectomy System | Experimental | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jetstream Atherectomy System | Device | Atherectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binary Restenosis | Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy | Index Procedure |
| Ankle-Brachial Index (ABI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Gray, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nelson Bernardo MD | Washington D.C. | District of Columbia | 20010 | United States | ||
| Robert Beasley, MD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Jetstream Atherectomy System | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Jetstream Atherectomy System | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy |
| 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 | Binary Restenosis | Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable. | Posted | Number | percentage of patients | 12 months |
|
Index procedure through 12 month follow up
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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 | Jetstream Atherectomy System | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target Vessel Revascularization/ Target Lesion Revascularization | Vascular disorders | Systematic Assessment | Device and/or Procedure Related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Artery Disease | Vascular disorders | Systematic Assessment | Includes target and non-target study limbs/lesions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DeeAnn Tinjum, Clinical Trial Manager | Boston Scientific | 763-494-1927 | deeann.tinjum@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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Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
| 30 days |
| Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | 6 months |
| Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | 12 months |
| Major Adverse Events (MAE) | Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days | 30 days |
| Miami |
| Florida |
| 33141 |
| United States |
| Nicolas Shammas, MD | Davenport | Iowa | 52803 | United States |
| Lawrence Garcia, MD | Boston | Massachusetts | 02135 | United States |
| Vinay Kumar | Laurel | Mississippi | 39440 | United States |
| Andrey Espinoza, MD | Flemington | New Jersey | 08822 | United States |
| Sotir Polena, MD | Huntington | New York | 11734 | United States |
| Rajesh Dave, MD | Harrisburg | Pennsylvania | 17110 | United States |
| Ali Amin, MD | West Reading | Pennsylvania | 19611 | United States |
| Lee Butterfield, MD | Columbia | South Carolina | 29204 | United States |
| Chris Metzger, MD | Kingsport | Tennessee | 37660 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Procedural Success | Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy | Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint | Posted | Number | percentage of patients | Index Procedure |
|
|
|
| Secondary | Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable. | Posted | Number | percentage of patients | 30 days |
|
|
|
| Secondary | Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable. | Posted | Number | percentage of patients | 6 months |
|
|
|
| Secondary | Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable. | Posted | Number | percentage of patients | 12 months |
|
|
|
| Secondary | Major Adverse Events (MAE) | Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable. | Posted | Number | Major Adverse Events | 30 days |
|
|
|
| 42 |
| 241 |
| 38 |
| 241 |
|
| Distal Embolization Requiring a Separate Intervention | Vascular disorders | Systematic Assessment | Device Related |
|
| Amputation | Surgical and medical procedures | Systematic Assessment | Device Related |
|
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |