Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2011-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with PAD
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium
Jetstream Atherectomy System
to perform atherectomy on calcified lesions
Interventions
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Jetstream Atherectomy System
to perform atherectomy on calcified lesions
Eligibility Criteria
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Inclusion Criteria
2. Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization.
3. The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
4. The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.
5. The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use.
6. The patient has signed approved informed consent.
7. Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography.
Exclusion Criteria
2. Patient is unable to take appropriate anti-platelet therapy.
3. Patient has no distal runoff vessels.
4. Deep wall calcium.
5. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
6. Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
7. Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
8. Patient is receiving hemodialysis or has impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
9. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
10. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
11. Patient is pregnant or nursing a child.
12. Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.
\-
18 Years
100 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Davis, MD
Role: PRINCIPAL_INVESTIGATOR
St. John Hospital
Malcolm Foster
Role: PRINCIPAL_INVESTIGATOR
Mercy Medical Center
Venkatesh Ramaiah, MD
Role: PRINCIPAL_INVESTIGATOR
Arizona Heart Institute
Joseph Ricotta, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Thomas Shimshak, MD
Role: PRINCIPAL_INVESTIGATOR
Wheaton Franciscan Healthcare
Locations
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Arizona Heart Institute
Phoenix, Arizona, United States
Emory University
Atlanta, Georgia, United States
St. John Hopital
Detroit, Michigan, United States
Mercy Medical Center
Knoxville, Tennessee, United States
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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D1139
Identifier Type: -
Identifier Source: org_study_id