The Jetstream G3™ Calcium Study

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Jetstream Atherectomy System

• Registration Number: NCT01273623
• Lead Sponsor: Boston Scientific Corporation

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-20
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2015-04-16
• Results First Submitted QC: 2015-04-16
• Results First Posted: 2015-05-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with PAD	Jetstream Atherectomy System	Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium

Primary Outcome Measures

Name	Time	Method
Luminal Area Change	Day 0	lumen area change as measured by intravascular ultrasound (IVUS)

Secondary Outcome Measures

Name	Time	Method
Adjunctive Therapy Use	Day 0
Residual Diameter Stenosis	Day 0	lumen diameter stenosis change post-atherectomy

Trial Locations

Locations (5)

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

St. John Hopital; 🇺🇸 Detroit, Michigan, United States

Mercy Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Wheaton Franciscan Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States