The Jetstream G3™ Calcium Study

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: Jetstream Atherectomy System	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Patients with PAD; Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium	Device: Jetstream Atherectomy System; to perform atherectomy on calcified lesions

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Luminal Area Change [ Time Frame: Day 0 ]
   lumen area change as measured by intravascular ultrasound (IVUS)

Secondary Outcome Measures :

1. Adjunctive Therapy Use [ Time Frame: Day 0 ]
2. Residual Diameter Stenosis [ Time Frame: Day 0 ]
   lumen diameter stenosis change post-atherectomy

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. The patient is ≥ 18 years of age.
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:

1. Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01273623 History of Changes
Other Study ID Numbers:	D1139
First Posted:	January 10, 2011
Results First Posted:	May 4, 2015
Last Update Posted:	November 18, 2015
Last Verified:	October 2015

Keywords provided by Boston Scientific Corporation:

PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis	Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases