Chronic Total OcclusionPhase 4Re-ROUTENCT01500031

Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

A Phase 4 study testing OffRoad Re-entry Catheter System in people with Chronic Total Occlusion, run by Boston Scientific Corporation.

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

Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Total Occlusion
What is being tested?: OffRoad Re-entry Catheter System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: No sites listed yet
Study dates: Apr 2012to May 2013
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Claudication or critical limb ischemia (Rutherford Category 2-5)
Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
Minimum reference vessel diameter is 4 mm

Who cannot join

Contraindication to an endovascular procedure
Previous stent placement in the target vessel
Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
Platelet count <150,000 mm3 or >600,000 mm3
Renal insufficiency with a serum creatinine >2.3 mg/dl
History of major amputation (ankle level or above) in the same limb as the target lesion
Current participation in another drug or device clinical study

About this study

Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.

Conditions: Chronic Total Occlusion
Being tested: OffRoad Re-entry Catheter System

What participants receive

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

OffRoad Re-entry Catheter SystemDevice
Facilitate the placement and positioning of guidewires within the peripheral vasculature.

Study groups in NCT01500031
Study group	Role	What they receive
OffRoad Re-entry catheter	Experimental	Participants treated with OffRoad Re-entry Catheter System Receives: Device: OffRoad Re-entry Catheter System

What is being measured

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

Composite Rate of Major Adverse Events
Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).
Events are based on data adjudicated by a Clinical Event Committee.
Measured: 30 days
Effectiveness (On the Day of Procedure)
Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)
Measured: Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body

Timeline

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

Apr 2012May 2013

First posted26 Dec 2011 (estimated)
Study startApr 2012
Primary completionApr 2013
Study completionMay 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 Chronic Total OcclusionStudies 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: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500031
Sponsor's protocol ID: S2273
Acronym: Re-ROUTE
Status last verified: Mar 2014
First submitted: 19 Dec 2011
Last updated: 15 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Schmidt A, Keirse K, Blessing E, Langhoff R, Diaz-Cartelle J; European Study Group. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino). 2014 Aug;55(4):551-8. Epub 2014 Jun 13.
PubMed 24926886

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 Chronic Total Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
ClinicalTrials.gov ID: NCT01500031
Acronym / sponsor ID: Re-ROUTE / S2273
Conditions: Chronic Total Occlusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Apr 2013 (actual)
Study completion: May 2013 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 15 Apr 2014

Clinical summary

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

Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.

Study design

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

Arm	Type	Receives
OffRoad Re-entry catheter	Experimental	Device: OffRoad Re-entry Catheter SystemParticipants treated with OffRoad Re-entry Catheter System

Who may qualify

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

Key inclusion criteria (4 listed)

Claudication or critical limb ischemia (Rutherford Category 2-5)
Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
Minimum reference vessel diameter is 4 mm

Key exclusion criteria (7 listed)

Contraindication to an endovascular procedure
Previous stent placement in the target vessel
Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
Platelet count <150,000 mm3 or >600,000 mm3
Renal insufficiency with a serum creatinine >2.3 mg/dl

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
OffRoad Re-entry Catheter SystemFacilitate the placement and positioning of guidewires within the peripheral vasculature.	Device	OffRoad Re-entry catheter

Primary outcome

Composite Rate of Major Adverse Events
Time frame: 30 days
Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above). Events are based on data adjudicated by a Clinical Event Committee.
Effectiveness (On the Day of Procedure)
Time frame: Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body
Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)

Results and safety

Results posted to the registry on 15 Apr 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
Re-ROUTE	92	87

Primary outcome: Composite Rate of Major Adverse Events

Time frame: 30 days. Number. Unit: percentage of participants

Measure	OffRoad Re-entry Catheter n = 90
Value	3.3

Population analysed: The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)

Primary outcome: Effectiveness (On the Day of Procedure)

Time frame: Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body. Number (95% Confidence Interval). Unit: percentage of participants

Measure	OffRoad Re-entry Catheter n = 92
Value	84.8 (77.4 to 92.1)

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
OffRoad Re-entry Catheter	21 of 92 (22.8%)	15 of 92 (16.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24926886Schmidt A, Keirse K, Blessing E, Langhoff R, Diaz-Cartelle J; European Study Group. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino). 2014 Aug;55(4):551-8. Epub 2014 Jun 13.

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Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
Chronic Total Occlusion (CTO), Frontal QRS-T Angle
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
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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.

Andrej Schmidt principal investigator

Herzzentrum Leipzig GmbH/ Park Krankenhaus Leipzig GmbH

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OffRoad Re-entry Catheter System in people with Chronic Total Occlusion, 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 4 inclusion and 7 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 15 Apr 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.

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 15 Apr 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?

Composite Rate of Major Adverse Events (time frame: 30 days). 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 NCT01500031, 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 15 Apr 2014.