The Jetstream G3™ Calcium Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01273623 |
Recruitment Status :
Completed
First Posted : January 10, 2011
Results First Posted : May 4, 2015
Last Update Posted : November 18, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Device: Jetstream Atherectomy System | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients with PAD
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium
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Device: Jetstream Atherectomy System
to perform atherectomy on calcified lesions |
- Luminal Area Change [ Time Frame: Day 0 ]lumen area change as measured by intravascular ultrasound (IVUS)
- Adjunctive Therapy Use [ Time Frame: Day 0 ]
- Residual Diameter Stenosis [ Time Frame: Day 0 ]lumen diameter stenosis change post-atherectomy

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient is ≥ 18 years of age.
- Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization.
- The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
- The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.
- The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use.
- The patient has signed approved informed consent.
- Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography.
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.
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Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273623
United States, Arizona | |
Arizona Heart Institute | |
Phoenix, Arizona, United States, 85006 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Michigan | |
St. John Hopital | |
Detroit, Michigan, United States, 48236 | |
United States, Tennessee | |
Mercy Medical Center | |
Knoxville, Tennessee, United States, 37934 | |
United States, Wisconsin | |
Wheaton Franciscan Healthcare | |
Milwaukee, Wisconsin, United States, 53210 |
Principal Investigator: | 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 |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT01273623 |
Other Study ID Numbers: |
D1139 |
First Posted: | January 10, 2011 Key Record Dates |
Results First Posted: | May 4, 2015 |
Last Update Posted: | November 18, 2015 |
Last Verified: | October 2015 |
PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |