The Jetstream G3™ Calcium Study

NCT01273623 | Completed Phase 4 Results

• 1 other identifier: D1139
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

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).

Conditions

Peripheral Arterial Disease

Keywords

PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream

Outcome Measures

Primary Outcomes (1)

• Luminal Area Change

  lumen area change as measured by intravascular ultrasound (IVUS)

  Day 0

Secondary Outcomes (2)

• Adjunctive Therapy Use

  Day 0

• Residual Diameter Stenosis

  Day 0

Study Arms (1)

Patients with PAD

EXPERIMENTAL

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

Device: Jetstream Atherectomy System

Interventions

Jetstream Atherectomy System DEVICE

to perform atherectomy on calcified lesions

Patients with PAD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

St. John Hopital

Detroit, Michigan, 48236, United States

Location

Mercy Medical Center

Knoxville, Tennessee, 37934, United States

Location

Wheaton Franciscan Healthcare

Milwaukee, Wisconsin, 53210, United States

Location

Related Publications (1)

• Yin D, Maehara A, Shimshak TM, Ricotta JJ 2nd, Ramaiah V, Foster MT 3rd, Davis TP, Matsumura M, Mintz GS, Gray WA. Intravascular Ultrasound Validation of Contemporary Angiographic Scores Evaluating the Severity of Calcification in Peripheral Arteries. J Endovasc Ther. 2017 Aug;24(4):478-487. doi: 10.1177/1526602817708796. Epub 2017 May 15.

  PMID: 28504047 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Susanna Kennedy
• Organization: Boston Scientific

susanna.kennedy@bsci.com

763.494.2601

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 18, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-10

Locations

US (5)