The Jetstream G3™ Calcium Study

• ClinicalTrials.gov Identifier: NCT01273623
• Recruitment Status: Completed
• First Posted: January 10, 2011
• Results First Posted: May 4, 2015
• Last Update Posted: November 18, 2015
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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

• 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

Arms and Interventions

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

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

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• 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

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

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
• 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