Peripheral Vascular DiseasePEARLIINCT01086215

Registry of AngioJet Use in the Peripheral Vascular System

An observational study of Peripheral Vascular Disease and Embolism and Thrombosis, run by Boston Scientific Corporation at 36 sites in 5 countries.

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

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system. Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral Vascular Disease, Embolism and Thrombosis, Venous Thrombosis
How many people: 500 participants
Where: 36 sitesin 5 countries
Study dates: Jan 2010to Sep 2013
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Community population

Who may be able to join

Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Who cannot join

Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.

Trial locations and contacts

36 sites in 5 countries.

Country

City, postcode or hospital

36 sites in 5 countries

United States32 sites

St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015
Cardiovascular Consultants
Bossier City, Louisiana, 71111
University of South Carolina
Charleston, South Carolina, 29401
Charleston Area Medical Center
Charleston, West Virginia, 25304
Cleveland Clinic
Cleveland, Ohio, 44195
Grant Medical Center
Columbus, Ohio, 43215
Good Samaritan Hospital
Dayton, Ohio, 45435
Iowa Health
Des Moines, Iowa, 50263
Duke University Medical Center
Durham, North Carolina, 27705
Chris Recknor PC
Gainesville, Georgia, 30501
Phoenix Heart, PLLC
Glendale, Arizona, 85306
Terrebonne General Medical Center
Houma, Louisiana, 70360
University of Florida- College of Medicine
Jacksonville, Florida, 32209
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Holston Valley Medical Center
Kingsport, Tennessee, 37660
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
Indiana University Health Arnett
Lafayette, Indiana, 47905
Regional Medical Center of Acadiana
Lafayette, Louisiana, 70506
Good Samaritan Hospital
Los Angeles, California, 90017
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mount Sinai School of Medicine
New York, New York, 10029
Christiana Care Health System
Newark, Delaware, 19718
Sacred Heart Hospital
Pensacola, Florida, 32504
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
John C. Lincoln Deer Valley Hospital
Phoenix, Arizona, 85029
Chilton Memorial Hospital
Pompton Plains, New Jersey, 07444
The Miriam Hospital
Providence, Rhode Island, 02906
The Reading Hospital & Medical Center
Reading, Pennsylvania, 19611
North Central Heart Institute
Sioux Falls, South Dakota, 57108
The University of Toledo Medical Center
Toledo, Ohio, 43614
Winchester Medical Center
Winchester, Virginia, 22601
Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada1 site

Winnipeg Regional Health Authority
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Germany1 site

Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe

Other trials in Germany

Italy1 site

University of Naples
Naples

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Slovakia1 site

National Institute of CV Diseases
Bratislava

Other trials in Slovakia

About this study

Official title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

Read the detailed description

The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Conditions: Peripheral Vascular Disease, Embolism and Thrombosis, Venous Thrombosis
Medical subject headings: Peripheral Vascular Diseases, Embolism and Thrombosis, Venous Thrombosis

What participants receive

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

Study groups in NCT01086215
Study group	Role	What they receive
Limb Ischemia		Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis		Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access		Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions		Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

What is being measured

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

Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.
1. complete occlusion (>90% occlusion);
2. substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
3. partial occlusion (<50% occlusion AND <3cm in length)
4. patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value.
Measured: Day 1
Rethrombosis
The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Measured: 3 Month , 6 Month and 12 Month Follow Up

Secondary outcomes (1)

Concomitant Treatments Used With the AngioJet® System
The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure
Measured: Day 1

Timeline

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

Jan 2010Sep 2013

First posted15 Mar 2010 (estimated)
Study startJan 2010
Primary completionJul 2013
Study completionSep 2013

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 Vascular 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086215
Sponsor's protocol ID: PEARLII
Acronym: PEARLII
Status last verified: Nov 2014
First submitted: 20 Jan 2010
Last updated: 10 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.
PubMed 25824314

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

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All Peripheral Vascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths
ClinicalTrials.gov ID: NCT01086215
Acronym / sponsor ID: PEARLII / PEARLII
Conditions: Peripheral Vascular Disease, Embolism and Thrombosis, Venous Thrombosis
Study type: Observational
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jul 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 15 Mar 2010 (estimated)
Results: Posted 3 Nov 2014

Clinical summary

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

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Limb Ischemia	–	–Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis	–	–Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access	–	–Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions	–	–Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Community population

Key inclusion criteria (2 listed)

Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Key exclusion criteria (1 listed)

Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.

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

Primary outcome

Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
Time frame: Day 1
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician. 1. complete occlusion (>90% occlusion); 2. substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length); 3. partial occlusion (<50% occlusion AND <3cm in length) 4. patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value.
Rethrombosis
Time frame: 3 Month , 6 Month and 12 Month Follow Up
The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.

1 secondary outcome

Concomitant Treatments Used With the AngioJet® System
Time frame: Day 1

Results and safety

Results posted to the registry on 3 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Limb Ischemia	212	176
Deep Vein Thrombosis	201	154
Hemodialysis Access	73	47
Other Thrombotic Conditions	14	11

Primary outcome: Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.

Time frame: Day 1. Mean (Standard Error). Unit: Units on a Scale

Measure	Limb Ischemia n = 212	Deep Vein Thrombosis n = 201	Hemodialysis Access n = 73	Other Thrombotic Conditions n = 14
Baseline Value	1.31 (0.03)	1.33 (0.03)	1.36 (0.06)	1.80 (0.16)
Final Value	3.76 (0.04)	3.73 (0.03)	3.87 (0.04)	3.75 (0.12)
Levels of Change	2.45 (0.05)	2.40 (0.04)	2.50 (0.07)	1.95 (0.18)

Limb Ischemia: p <0.0001, Mixed Models Analysis
Deep Vein Thrombosis: p <0.0001, Mixed Models Analysis
Hemodialysis Access: p <0.0001, Mixed Models Analysis

Population analysed: Intention to Treat (ITT)

Primary outcome: Rethrombosis

Time frame: 3 Month , 6 Month and 12 Month Follow Up. Number. Unit: participants

Measure	Limb Ischemia n = 212	Deep Vein Thrombosis n = 201	Hemodialysis Access n = 73
3 Month Follow Up	21	22	15
6 Month Follow Up	9	4	12
12 Month Follow Up	9	3	7

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Index Procedure thru 12 Month Follow Up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Limb Ischemia	2 of 212 (0.9%)	0 of 212 (0%)	Not reported
Deep Vein Thrombosis	2 of 201 (1%)	0 of 201 (0%)	Not reported
Hemodialysis Access	0 of 73 (0%)	0 of 73 (0%)	Not reported
Other Thrombotic Conditions	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25824314Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.

Related trials for Peripheral Vascular Disease

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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RecruitingPhase 3
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Recruiting
The THOR IDE Study
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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.

Lawrence Blitz, MD principal investigator

Chilton Memorial Hospital

Robert Lookstein, MD study director

Icahn School of Medicine at Mount Sinai

Ali Amin, MD principal investigator

The Reading Hospital & Medical Center

36 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Vascular Disease and Embolism and Thrombosis, run by Boston Scientific Corporation at 36 sites in 5 countries.

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 2 inclusion and 1 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada, Germany, Italy, Slovakia. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2014). 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?

Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT01086215, 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 10 Nov 2014.