The Jetstream G3™ Calcium Study

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273623
• Other study ID #: D1139
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2010
• Last updated: October 19, 2015
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Jetstream Atherectomy System
to perform atherectomy on calcified lesions

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	St. John Hopital	Detroit	Michigan
United States	Mercy Medical Center	Knoxville	Tennessee
United States	Wheaton Franciscan Healthcare	Milwaukee	Wisconsin
United States	Arizona Heart Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Luminal Area Change	lumen area change as measured by intravascular ultrasound (IVUS)	Day 0	No
Secondary	Adjunctive Therapy Use		Day 0	No
Secondary	Residual Diameter Stenosis	lumen diameter stenosis change post-atherectomy	Day 0	No