Peripheral Arterial DiseasePADNCT03346577
Endovascular Treatment of Peripheral Artery Disease
An observational study of Peripheral Arterial Disease and Iliac Artery Disease, run by be Medical at 1 site in Belgium.
Trial summary
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Iliac Artery Disease, Below-the-knee Obstruction
- What is being tested?
- stent or balloon
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2018to 1 Oct 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral artery disease, located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
Who may be able to join
- Patient must sign the informed consent form prior to the index-procedure.
- Patient is older than 18 years.
- Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
- Patient suffers from intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
- Target lesion is an occlusion or diameter stenosis is ≥70% by visual estimate.
- Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery) .
Who cannot join
- Patients with Rutherford 0, 1 and 6.
- Patient is pregnant.
- Patients with serum creatinine >2.0 mg/dL or renal dialysis.
- Patient has an acute thrombus or aneurysm in the target arteries.
- Patient has a life expectancy of <12 months.
- Patient with bypass that involves the target arteries.
Show all 11Show fewer
- Patient has a target lesion that cannot be crossed with a guidewire.
- Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
- Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
- Contraindication for anti-thrombotic therapy (coagulopathy, …).
- Patient has a known intolerance to anti-thrombotic medication or contrast agents.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Below-the-knee Obstruction, Femoropopliteal Occlusive Disease
- Being tested
- stent or balloon
- 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.
stent or balloonDevice
Also called Optimed Sinus Superflex 635 stent, Cardionovum Legflow balloon, Optimed Nylotrack .035 + .018 balloons
Endovascular treatment with stent or balloon according to current practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with peripheral artery disease | located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). Receives: Device: stent or balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary restenosis
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4)
Measured: at 12 months follow-up
Secondary outcomes (11)
Device-related complications
Registration of peri- and early/late postoperative complications
Measured: up to 12 months follow-up
Immediate procedural outcome
The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of <30% of the treated target lesion on the procedural completion angiography.
and procedural success defined as a combination of technical success and absence of procedural complications.
Measured: up to 12 months follow-up
Clinical outcome
Rutherford classification
Measured: at baseline
Clinical outcome
Rutherford classification
Measured: at 6 weeks follow-up
Clinical outcome
Rutherford classification
Measured: at 12 months follow-up
Primary sustained clinical improvement
defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.
Measured: at 12 months follow-up
Secondary sustained clinical improvement
defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.
Measured: at 12 months follow-up
Target lesion revascularization (TLR)
defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena).
Measured: up to 12 months follow-up
Mortality
Procedure-related and all-cause mortality.
Measured: up to 12 months follow-up
Amputation
minor amputation defined as below the ankle and major defined as above the ankle.
Measured: up to 12 months follow-up
Stent fracture
Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used).
Measured: up to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start2 May 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Termination of collaboration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346577
- Sponsor's protocol ID
- BM-PAD-01
- Acronym
- PAD
- Status last verified
- Jan 2021
- First submitted
- 15 Nov 2017
- Last updated
- 14 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT03346577
- Acronym / sponsor ID
- PAD / BM-PAD-01
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Below-the-knee Obstruction, Femoropopliteal Occlusive Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of collaboration
- Enrolment
- 60 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral artery disease | – | Device: stent or balloonlocated in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral artery disease, located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
Key inclusion criteria (6 listed)
- Patient must sign the informed consent form prior to the index-procedure.
- Patient is older than 18 years.
- Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
- Patient suffers from intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
- Target lesion is an occlusion or diameter stenosis is ≥70% by visual estimate.
Key exclusion criteria (11 listed)
- Patients with Rutherford 0, 1 and 6.
- Patient is pregnant.
- Patients with serum creatinine >2.0 mg/dL or renal dialysis.
- Patient has an acute thrombus or aneurysm in the target arteries.
- Patient has a life expectancy of <12 months.
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 |
|---|---|---|
| stent or balloonAlso: Optimed Sinus Superflex 635 stent, Cardionovum Legflow balloon, Optimed Nylotrack .035 + .018 balloonsEndovascular treatment with stent or balloon according to current practice | Device | Patients with peripheral artery disease |
Primary outcome
Binary restenosis
Time frame: at 12 months follow-up
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4)
11 secondary outcomes
Device-related complications
Time frame: up to 12 months follow-up
Immediate procedural outcome
Time frame: up to 12 months follow-up
Clinical outcome
Time frame: at baseline
Clinical outcome
Time frame: at 6 weeks follow-up
Clinical outcome
Time frame: at 12 months follow-up
Primary sustained clinical improvement
Time frame: at 12 months follow-up
Secondary sustained clinical improvement
Time frame: at 12 months follow-up
Target lesion revascularization (TLR)
Time frame: up to 12 months follow-up
Mortality
Time frame: up to 12 months follow-up
Amputation
Time frame: up to 12 months follow-up
Stent fracture
Time frame: up to 12 months follow-up
Results and safety
The study was stopped early (reason given: Termination of collaboration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Iliac Artery Disease, run by be Medical at 1 site in Belgium.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study was stopped early (reason given: Termination of collaboration). Results are not available in the source record.
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?
Binary restenosis (time frame: at 12 months follow-up). 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 14 Jan 2021.