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: April 16, 2015
Last verified: April 2015
  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 intravascular ultrasound (IVUS).


Condition Intervention Phase
Peripheral Arterial Disease
Device: Jetstream Atherectomy System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Boston Scientific Corporation:

Primary Outcome Measures:
  • Luminal Gain [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    lumen area change as measured by IVUS


Secondary Outcome Measures:
  • 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 reduction post-atherectomy


Enrollment: 55
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with PAD
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium
Device: Jetstream Atherectomy System
to perform atherectomy on calcified lesions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium

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, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Michigan
St. John Hopital
Detroit, Michigan, United States, 48236
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
Boston Scientific Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01273623     History of Changes
Other Study ID Numbers: D1139
Study First Received: December 20, 2010
Results First Received: April 16, 2015
Last Updated: April 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
PAD, Periperhal Arterial Disease, Calcium, Atherectomy, Jetstream

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

ClinicalTrials.gov processed this record on May 04, 2015