The Jetstream G3™ Calcium Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01273623
First received: December 20, 2010
Last updated: October 19, 2015
Last verified: October 2015

December 20, 2010
October 19, 2015
January 2011
March 2012   (final data collection date for primary outcome measure)
Luminal Area Change [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
lumen area change as measured by intravascular ultrasound (IVUS)
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
Complete list of historical versions of study NCT01273623 on ClinicalTrials.gov Archive Site
  • Adjunctive Therapy Use [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Residual Diameter Stenosis [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    lumen diameter stenosis change post-atherectomy
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
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 intravascular ultrasound (IVUS).
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: Jetstream Atherectomy System
to perform atherectomy on calcified lesions
Experimental: Patients with PAD
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium
Intervention: Device: Jetstream Atherectomy System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
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 to 100 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01273623
D1139
No
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Tom Davis, MD St. John Hospital
Principal Investigator: Malcolm Foster Mercy Medical Center
Principal Investigator: Venkatesh Ramaiah, MD Arizona Heart Institute
Principal Investigator: Joseph Ricotta, MD Emory University
Principal Investigator: Thomas Shimshak, MD Wheaton Franciscan Healthcare
Boston Scientific Corporation
October 2015

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