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Clinical Trials/NCT01273623
NCT01273623CompletedPhase 4

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

Boston Scientific Corporation5 sites in 1 country55 target enrollmentStarted: January 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
55
Locations
5
Primary Endpoint
Luminal Area Change
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The patient is ≥ 18 years of age.
  • •Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization.
  • •The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
  • •The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.
  • •The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use.
  • •The patient has signed approved informed consent.
  • •Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography.

Exclusion Criteria

  • •Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
  • •Patient is unable to take appropriate anti-platelet therapy.
  • •Patient has no distal runoff vessels.
  • •Deep wall calcium.
  • •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
  • •Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or tortuosity at the treatment segment.
  • •Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
  • •Patient is receiving hemodialysis or has impaired renal function (creatinine is > 2.5 mg/dl) at the time of treatment.
  • •Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
  • •Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  • •Patient is pregnant or nursing a child.
  • •Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.

Arms & Interventions

Patients with PAD

Experimental

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

Intervention: Jetstream Atherectomy System (Device)

Outcomes

Primary Outcomes

Luminal Area Change

Time Frame: Day 0

lumen area change as measured by intravascular ultrasound (IVUS)

Secondary Outcomes

  • Adjunctive Therapy Use(Day 0)
  • Residual Diameter Stenosis(Day 0)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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