Femoropopliteal Occlusive DiseasePhase 3APOLO-IINCT01884701
Accessing Peripheral Occluded LesiOns II (APOLO-II)
A Phase 3 study testing ENABLER-P Catheter System in people with Femoropopliteal Occlusive Disease, run by EndoCross Ltd..
Trial summary
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Femoropopliteal Occlusive Disease
- What is being tested?
- ENABLER-P Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing;
- Patient must have objective evidence of lower extremity ischemia;
- Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible;
- Target occlusion length is >1cm and ≤ 30 cm;
- Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation)
- Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation;
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- Female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure;
- Patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent;
- Patient is ≥ 21 years of age.
Who cannot join
- Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated;
- The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels;
- Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure;
- The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period;
- Patient has no collateral flow distal to the occlusion;
- Patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt;
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- Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency;
- Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding;
- Patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus;
- Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.
About this study
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.
- Conditions
- Femoropopliteal Occlusive Disease
- Being tested
- ENABLER-P Catheter System
- Keywords
- Chronic Total Occlusion CTO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENABLER-P Catheter SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Receives: Device: ENABLER-P Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events ("MAEs"), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections.
Measured: 30 days (+/-7 days)
Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire.
Measured: 30 days (+/-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Occlusive DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoCross Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884701
- Sponsor's protocol ID
- IVO-031
- Acronym
- APOLO-II
- Status last verified
- Mar 2015
- First submitted
- 19 Jun 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessing Peripheral Occluded LesiOns II (APOLO-II)
- ClinicalTrials.gov ID
- NCT01884701
- Acronym / sponsor ID
- APOLO-II / IVO-031
- Conditions
- Femoropopliteal Occlusive Disease
- Keywords
- Chronic Total Occlusion CTO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EndoCross Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2016 (estimated)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: ENABLER-P Catheter SystemIntervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing;
- Patient must have objective evidence of lower extremity ischemia;
- Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible;
- Target occlusion length is >1cm and ≤ 30 cm;
- Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation)
Key exclusion criteria (10 listed)
- Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated;
- The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels;
- Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure;
- The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period;
- Patient has no collateral flow distal to the occlusion;
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 |
|---|---|---|
| ENABLER-P Catheter System | Device | Intervention |
Primary outcome
The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events ("MAEs"), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections.
Time frame: 30 days (+/-7 days)
Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire.
Time frame: 30 days (+/-7 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENABLER-P Catheter System in people with Femoropopliteal Occlusive Disease, run by EndoCross Ltd..
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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 Oct 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events ("MAEs"), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections. (time frame: 30 days (+/-7 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?
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 2016.