Clinical trial NCT01273623: The Jetstream G3™ Calcium Study
Official title: A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

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Primary outcomes:
measure: Luminal Area Change
timeFrame: Day 0
Secondary outcomes:
measure: Adjunctive Therapy Use
timeFrame: Day 0
measure: Residual Diameter Stenosis
timeFrame: Day 0
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: St. John Hopital
state: Michigan
city: Knoxville
country: United States
facility: Mercy Medical Center
state: Tennessee
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: St. John Hospital
name: Tom Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Medical Center
name: Malcolm Foster
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Institute
name: Venkatesh Ramaiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Joseph Ricotta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wheaton Franciscan Healthcare
name: Thomas Shimshak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.