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
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: Jetstream
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions

Resource links provided by NLM:


Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 53
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease
Device: Jetstream
The Jetstream G3 System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273623

Locations
United States, Tennessee
Mercy Medical Center
Knoxville, Tennessee, United States, 37934
United States, Wisconsin
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, United States, 53210
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT01273623     History of Changes
Other Study ID Numbers: D1139, post-market registry
Study First Received: December 20, 2010
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MEDRAD, Inc.:
PAD, Periperhal Arterial Disease, Calcium, Atherectomy, Pathway, Jetstream

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014