Peripheral Arterial DiseaseNCT01420120
Remedy, Biodegradable Peripheral Stent Registry
An observational study of Peripheral Arterial Disease, run by be Medical at 1 site in Belgium.
Trial summary
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Sep 2014
- 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 documented symptomatic occlusion and/or > 70% stenosis of SFA.
Who may be able to join
- Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
- 1 cm from the femoral bifurcation in the SFA
- 3 cm from the proximal margin of the intercondylar fossa
- Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
- Single lesion which can be covered by one stent.
- Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
- A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography
- Signed informed consent.
Who cannot join
- Pregnancy
- Previous stenting of target lesion
- Acute ischemia
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Known intolerance to study medications or contrast agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Biodegradable stent, PAD
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of clinically driven target lesion revascularization at 12 months.
Measured: 12 months
Secondary outcomes (7)
Technical success
Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.
Measured: During procedure
Clinical success
Defined as technical success without the occurrence of serious adverse events during procedure
Measured: During procedure
Primary and secondary patency rate
defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.
Measured: 12 months
Ankle-Brachial Index improvement of ≥ 0.1
Measured: 1, 6 and 12 months
Clinically driven target vessel revascularization
Measured: 6 and 12 months
Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.
Measured: 6 and 12 months
Rutherford-Becker classification of chronic limb ischemia
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionSep 2014
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420120
- Sponsor's protocol ID
- BM-REM-03-003
- Status last verified
- Jul 2015
- First submitted
- 16 Aug 2011
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
- ClinicalTrials.gov ID
- NCT01420120
- Acronym / sponsor ID
- BM-REM-03-003
- Conditions
- Peripheral Arterial Disease
- Keywords
- Biodegradable stent, PAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Aug 2011 (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.
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented symptomatic occlusion and/or > 70% stenosis of SFA.
Key inclusion criteria (8 listed)
- Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
- Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
- Single lesion which can be covered by one stent.
- Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
- A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography
Key exclusion criteria (6 listed)
- Pregnancy
- Previous stenting of target lesion
- Acute ischemia
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
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
Absence of clinically driven target lesion revascularization at 12 months.
Time frame: 12 months
7 secondary outcomes
Technical success
Time frame: During procedure
Clinical success
Time frame: During procedure
Primary and secondary patency rate
Time frame: 12 months
Ankle-Brachial Index improvement of ≥ 0.1
Time frame: 1, 6 and 12 months
Clinically driven target vessel revascularization
Time frame: 6 and 12 months
Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.
Time frame: 6 and 12 months
Rutherford-Becker classification of chronic limb ischemia
Time frame: 1, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Peripheral Arterial Disease
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, 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 8 inclusion and 6 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 16 Jul 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absence of clinically driven target lesion revascularization at 12 months. (time frame: 12 months). 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 16 Jul 2015.