Peripheral Vascular DiseasesNCT00778336

A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

An observational study of Peripheral Vascular Diseases and Thrombosis, run by Boston Scientific Corporation.

Completed

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

Trial summary

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice. Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis
How many people: 452 participants
Where: No sites listed yet
Study dates: Jan 2007to Apr 2010
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: Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

Who may be able to join

Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
Patient has provided appropriate authorization per institutional policy and procedure.

Who cannot join

None

About this study

Official title: Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

Read the detailed description

The PEARL Registry collects real world data about mid-length AngioJet catheters to:

Characterize usage patterns, treatment approaches, and targeted vessels
Document treatment strategies, including specific techniques and concomitant therapies
Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines
Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

Conditions: Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis
Keywords: Peripheral Thrombosis, DVT, Limb Ischemia, AV Access, AngioJet, Thrombectomy
Medical subject headings: Peripheral Vascular Diseases, 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 NCT00778336
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 thrombosed conditions 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 From Baseline to Final Angiographic Results
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,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 value from the final value.
Measured: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)

Secondary outcomes (2)

Rethrombosis
The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).
Measured: 3 Month Follow Up
Description of Treatments by Thrombotic Condition
The # of patients that were exposed to each treatment at least once in the given thrombotic condition.
Measured: Index Procedure

Timeline

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

Jan 2007Apr 2010

First posted23 Oct 2008 (estimated)
Study startJan 2007
Primary completionMar 2010
Study completionApr 2010

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.
Other trials for Peripheral Vascular DiseasesStudies 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: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00778336
Sponsor's protocol ID: PEARL
Status last verified: Oct 2014
First submitted: 22 Oct 2008
Last updated: 17 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

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All Peripheral Vascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
ClinicalTrials.gov ID: NCT00778336
Acronym / sponsor ID: PEARL
Conditions: Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis
Keywords: Peripheral Thrombosis, DVT, Limb Ischemia, AV Access, AngioJet, Thrombectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Mar 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 23 Oct 2008 (estimated)
Results: Posted 26 Apr 2011

Clinical summary

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

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

Detailed description

The PEARL Registry collects real world data about mid-length AngioJet catheters to:

Characterize usage patterns, treatment approaches, and targeted vessels
Document treatment strategies, including specific techniques and concomitant therapies
Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines
Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

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 thrombosed conditions 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: Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

Key inclusion criteria (2 listed)

Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
Patient has provided appropriate authorization per institutional policy and procedure.

Key exclusion criteria (1 listed)

None

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 From Baseline to Final Angiographic Results
Time frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,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 value from the final value.

2 secondary outcomes

Rethrombosis
Time frame: 3 Month Follow Up
Description of Treatments by Thrombotic Condition
Time frame: Index Procedure

Results and safety

Results posted to the registry on 26 Apr 2011, 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	198	192
Deep Vein Thrombosis	170	167
Hemodialysis Access	72	70
Other Thrombotic Conditions	12	12

Primary outcome: Change From Baseline to Final Angiographic Results

Time frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment). Mean (Standard Error). Unit: Occlusion Index

Measure	Limb Ischemia n = 198	Deep Vein Thrombosis n = 170	Hemodialysis Access n = 72	Other Thrombotic Conditions n = 12
Baseline (pre-treatment) Angiograph Value	1.32 (0.04)	1.37 (0.04)	1.16 (0.05)	1.89 (0.14)
Final (post-treatment) Angiograph Value	3.67 (0.05)	3.67 (0.04)	3.80 (0.07)	3.54 (0.14)
Levels of Change (baseline minus final values)	2.36 (0.06)	2.30 (0.05)	2.63 (0.08)	1.63 (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)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Index procedure thru Discharge, 3 Month Follow Up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Limb Ischemia	6 of 198 (3%)	0 of 198 (0%)	Not reported
Deep Vein Thrombosis	2 of 170 (1.2%)	0 of 170 (0%)	Not reported
Hemodialysis Access	0 of 72 (0%)	0 of 72 (0%)	Not reported
Other Thrombotic Conditions	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): Non randomized observational registry

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Vascular Diseases

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
Diabetes, Peripheral Neuropathy
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis

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 R. Blitz, MD principal investigator

Chilton Memorial Hospital, Pompton Plains, NJ

Robert Lookstein, MD principal investigator

Mount Sinai School of Medicine, NYC, NY

Eugene Simoni, MD principal investigator

Samaritan Vascular Institute, Dayton, OH

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Vascular Diseases and Thrombosis, run by Boston Scientific Corporation.

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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

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 26 Apr 2011). 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 From Baseline to Final Angiographic Results (time frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)). 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 NCT00778336.

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 17 Oct 2014.