The Jetstream G3™ Calcium Study

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Device: Jetstream Atherectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01273623

D1139

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Patients with PAD

Experimental group

Description:

Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium

Treatment:

Device: Jetstream Atherectomy System