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A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Experimental | Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB |
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| POBA+DCB (Ranger or IN.PACT) | Active Comparator | POBA and then DCB treatment (Ranger or IN.PACT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm | Device | Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization | Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis) | 1 year |
| Major Adverse Events | Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting) | 30 Days |
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Inclusion Criteria:
Subject must meet all of the following general inclusion criteria.
Angiographic Inclusion Criteria:
Subject must meet all of the following angiographic inclusion criteria. Unless otherwise specified, the Investigator performing the procedure bases all angiographic inclusion criteria on visual determination at the time of the procedure.
General Exclusion Criteria:
The subject must not meet any of the following general exclusion criteria.
Angiographic Exclusion Criteria:
The subject must not meet any of the following angiographic exclusion criteria. The Investigator performing the procedure bases all angiographic exclusion criteria on visual determination at the time of the procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Shammas, MD, Research Director | MCRF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2016 |
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255 subjects are planned for enrollment (with a block 2:1 randomization)
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| FG001 | POBA+DCB (Ranger or IN.PACT) | POBA and then DCB treatment (Ranger or IN.PACT) Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB |
| BG001 | POBA+DCB (Ranger or IN.PACT) | Balloon angioplasty followed by adjunctive DCB treatment (Ranger or IN.PACT) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Target Lesion Revascularization | Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis) | Posted | Number | participants | 1 year |
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| Primary | Major Adverse Events | Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting) | Posted | Number | participants | 30 Days |
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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 | Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB | 0 | 31 | 0 | 31 | 2 | 31 |
| EG001 | POBA+DCB (Ranger or IN.PACT) | POBA and then DCB treatment (Ranger or IN.PACT) | 0 | 16 | 8 | 16 | 1 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target Lesion Revascularization | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type D Dissection | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicolas W Shammas | Midwest Cardiovascular Research Foundation | 5633242828 | shammas@mchsi.com |
| Apr 27, 2026 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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