The Jetstream G3™ Calcium Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01273623
First received: December 20, 2010
Last updated: April 8, 2014
Last verified: April 2014

December 20, 2010
April 8, 2014
January 2011
March 2012   (final data collection date for primary outcome measure)
Calcium Removal [ Time Frame: January 2010-December 2011 ] [ Designated as safety issue: No ]
Calcium removal and luminal gain as measured by IVUS pre and post Jetstream treatment
Same as current
Complete list of historical versions of study NCT01273623 on ClinicalTrials.gov Archive Site
Secondary Endpoints [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • MAE at 30 days
  • Adjunctive therapy use
  • Residual diameter stenosis
  • Preservation of run-off
Same as current
Not Provided
Not Provided
 
The Jetstream G3™ Calcium Study
A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions

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 IVUS.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: Jetstream
The Jetstream G3 System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.
Experimental: Calcium
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease
Intervention: Device: Jetstream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2012
March 2012   (final data collection date for primary outcome measure)

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.

    -

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01273623
D1139, post-market registry
No
MEDRAD, Inc.
MEDRAD, Inc.
Not Provided
Principal Investigator: William Gray, MD Center for Interventional Vascular Therapy-Columbia Medical
Principal Investigator: Thomas Shimshak, MD Wheaton Franciscan Healthcare
Principal Investigator: Venkatesh Ramaiah, MD Arizona Heart
Principal Investigator: Tom Davis, MD St. Johns Medical Center Detroit
Principal Investigator: Anvar Babaev, MD NYU School of Medicine
MEDRAD, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP