Peripheral Arterial DiseasePhase 4NCT01273623

The Jetstream G3™ Calcium Study

A Phase 4 study testing Jetstream Atherectomy System in people with Peripheral Arterial Disease, run by Boston Scientific Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Jetstream Atherectomy System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 5 sitesUnited States
Study dates: Jan 2011to Mar 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.
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Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Emory University
Atlanta, Georgia, 30322
St. John Hopital
Detroit, Michigan, 48236
Mercy Medical Center
Knoxville, Tennessee, 37934
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, 53210
Arizona Heart Institute
Phoenix, Arizona, 85006

Other trials in United States

About this study

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

Conditions: Peripheral Arterial Disease
Being tested: Jetstream Atherectomy System
Keywords: PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jetstream Atherectomy SystemDevice
to perform atherectomy on calcified lesions

Study groups in NCT01273623
Study group	Role	What they receive
Patients with PAD	Experimental	Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium Receives: Device: Jetstream Atherectomy System

What is being measured

The primary outcome is the main question the study is designed to answer.

Luminal Area Change
lumen area change as measured by intravascular ultrasound (IVUS)
Measured: Day 0

Secondary outcomes (2)

Adjunctive Therapy Use
Measured: Day 0
Residual Diameter Stenosis
lumen diameter stenosis change post-atherectomy
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Mar 2012

First posted10 Jan 2011 (estimated)
Study startJan 2011
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01273623
Sponsor's protocol ID: D1139
Status last verified: Oct 2015
First submitted: 20 Dec 2010
Last updated: 18 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28504047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions
ClinicalTrials.gov ID: NCT01273623
Acronym / sponsor ID: D1139
Conditions: Peripheral Arterial Disease
Keywords: PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 4 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with PAD	Experimental	Device: Jetstream Atherectomy SystemPatients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jetstream Atherectomy Systemto perform atherectomy on calcified lesions	Device	Patients with PAD

Primary outcome

Luminal Area Change
Time frame: Day 0
lumen area change as measured by intravascular ultrasound (IVUS)

2 secondary outcomes

Adjunctive Therapy Use
Time frame: Day 0
Residual Diameter Stenosis
Time frame: Day 0

Results and safety

Results posted to the registry on 4 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	55	26

Primary outcome: Luminal Area Change

Time frame: Day 0. Mean (Standard Deviation). Unit: mm^2

Measure	Pre-atherectomy n = 26	Post-atherectomy n = 26
Value	5.1 (2.8)	8.3 (2.6)

Pre-atherectomy vs Post-atherectomy: p <0.0001, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: through 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Participants	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28504047Yin 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.

Related trials for Peripheral Arterial Disease

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tom Davis, MD principal investigator

St. John Hospital

Malcolm Foster principal investigator

Mercy Medical Center

Venkatesh Ramaiah, MD principal investigator

Arizona Heart Institute

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Jetstream Atherectomy System in people with Peripheral Arterial Disease, run by Boston Scientific Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Luminal Area Change (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01273623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.