Peripheral Artery DiseaseRECAMNCT02011984
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system
An observational study of Peripheral Artery Disease, run by Eucatech AG at 5 sites in 2 countries.
Trial summary
Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 120 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2013to Feb 2017
- How long will I take part?
- 2 Years
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with de novo stenotic lesions in the superficial femoral artery
Who may be able to join
- Age of 18 to 95 years
- Male or non-pregnant female
- De novo lesions>70% or occlusions in the SFA (Superficial Femoral Artery) arteries suitable for stent angioplasty
- Max. 1 lesion within each leg should be treated as study lesions
- Lesions length range from ≥3 cm to ≤18 cm
- A patent inflow artery free from significant lesions (>50 % stenosis) as confirmed by angiography. Treatment of target lesion acceptable after successful treatment of inflow artery lesions.
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- Reference vessel diameter ≥3 mm and ≤ 7 mm
- Successful guide wire passage of the lesion
- Symptomatic peripheral artery disease (Rutherford stage 2 to 5)
- Patient is willing to provide informed consent and comply with the required follow-up visits, testing schedule, and medication regimen
Who cannot join
- Patients for whom an anti-platelet therapy, anticoagulants or thrombolytics are contraindicated
- Patients presenting a lasting intraluminal thrombosis at the lesion after a thrombolytic therapy
- Perforation at the location of the angioplasty characterized by secretion of the contrast medium
- Aneurysm of the artery to be treated
- All common contraindications for a PTA (Percutaneous Transluminal Angioplasty)
- Contraindications for stent angioplasty
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- Hypersensitivity/allergy to nickel-titanium
- Hypersensitivity/allergy to any of the components of the delivery \& dilation system
- Severe renal insufficiency (creatinine>2.0 mg/dL or glomerular filtration rate < 60 ml/min/1.73)
- Uncorrected bleeding disorder
- Major gastrointestinal bleeding within the last 6 months.
- Ipsilateral intervention other than target vessel
- Untreated ipsilateral iliac artery stenosis >70 %
- Previous stenting or prior surgery of the SFA
- In-stent restenosis
- Acute myocardial infarct within 72 h
- Less than one patent crural artery
- Popliteal stenosis > 70 %
- Manifest hyperthyroidism
- Acute onset of symptoms
- Leg-threatening ischemia
- Multimorbid patient with poor general condition
- Pregnant woman or becoming pregnant in < 2 yrs
- Living more than 100 km apart from the study center
- Patient actively participating in another investigational device or drug study
- History of hemorrhagic stroke within 3 months
- Previous or planned surgical or interventional procedure within 30 days of the procedure
- Acute or sub-acute thrombus in target vessel
- Acute vessel occlusion or sudden symptom onset
- Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery
- Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
Augusta-Krankenhaus, Klinik für Gefäßchrirugie
Düsseldorf, North Rhine-Westphalia, 40472
Ralf Kolvenbach, Prof., 0049 211 9043 ext. 301, kolvenbach@vkkd-kliniken.de
Ralf Kolvenbach, Prof.
- Recruiting
Uniklinikum Freiburg, Abteilung Röntgendiagnostik
Freiburg im Breisgau, Baden-Wurttemberg, 79095
Wulf Euringer, M.D., 0049 761 270 ext. 38580, wulf.euringer@uniklinik-freiburg.de
Wulf Euringer, M.D.
- Recruiting
Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
Marburg, Hesse, 35043
Mykhaylo Burbelko, M.D., 0049 6421 58 ext. 65912, burbelko@med.uni-marburg.de
Mykhaylo Burbelko, M.D.
- Recruiting
Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
Zwickau, Saxony, 08060
Jörg Thalwitzer, M.D., 0049 375 ext. -4854/-4855, irad@hbk-zwickau.de
Jörg Thalwitzer, M.D.
Italy1 site, 1 recruiting
- Recruiting
CCP - Istituto di Cura "Città di Pavia"
Pavia, Lombardy, 27100
Cesare Massa Saluzzo, M.D., 0039 3349419996, segreteria@centroendovascolare.it
Cesare Massa Saluzzo, M.D.
About this study
Official title: Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries
Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty.
The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.
Read the detailed description
The aim of this non-randomized post-market clinical follow-up study is to confirm long-term safety and effectiveness of the CE-approved Camouflage-coated self expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in superficial femoral artery in 120 compliant patients suitable for stent angioplasty. The primary end point is the target lesion revascularization after 12 months. Further follow-ups are scheduled at discharge, 30 days, 6 and 24 months.
- Conditions
- Peripheral Artery Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| peripheral artery disease | de novo stenotic lesions in superficial femoral artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion revascularization (TLR)
Target lesion revascularization (TLR) rate
Measured: 12 months
Secondary outcomes (21)
Adverse Event
Adverse Event rate
Measured: 24 hours
Adverse Event
Adverse Event rate
Measured: 48 hours
Adverse Event
Adverse Event rate
Measured: 6 months
Adverse Event
Adverse Event rate
Measured: 12 months
Adverse Event
Adverse Event rate
Measured: 24 months
Technical success
The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.
Measured: 24 hours
Procedural success
Procedural success rate
Measured: 24 hours
Walking Impairment Questionnaire
Change from baseline in Walking Impairment Questionnaire scores
Measured: 6 months
Walking Impairment Questionnaire
Change from baseline in Walking Impairment Questionnaire scores
Measured: 12 months
Rutherford classification
Change from baseline in Rutherford stage
Measured: 48 hours
Rutherford classification
Change from baseline in Rutherford stage
Measured: 6 months
Rutherford classification
Change from baseline in Rutherford stage
Measured: 12 months
Rutherford classification
Change from baseline in Rutherford stage
Measured: 24 months
Health-related quality of life (SF-36 questionnaire)
Change from baseline in health-related quality of life (SF-36 questionnaire scores)
Measured: 12 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
Measured: 6 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
Measured: 12 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
Measured: 24 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Measured: 48 hours
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Measured: 6 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Measured: 12 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Eucatech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Giese, Phd, Study chair, Eucatech AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011984
- Sponsor's protocol ID
- recam2013_eucatech
- Other IDs
- ECT024ResiCSfaRegV10
- Acronym
- RECAM
- Status last verified
- Feb 2015
- First submitted
- 15 Nov 2013
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries
- ClinicalTrials.gov ID
- NCT02011984
- Acronym / sponsor ID
- RECAM / recam2013_eucatech
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Eucatech AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 16 Dec 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.
Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty.
The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.
Detailed description
The aim of this non-randomized post-market clinical follow-up study is to confirm long-term safety and effectiveness of the CE-approved Camouflage-coated self expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in superficial femoral artery in 120 compliant patients suitable for stent angioplasty. The primary end point is the target lesion revascularization after 12 months. Further follow-ups are scheduled at discharge, 30 days, 6 and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peripheral artery disease | – | –de novo stenotic lesions in superficial femoral artery |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with de novo stenotic lesions in the superficial femoral artery
Key inclusion criteria (10 listed)
- Age of 18 to 95 years
- Male or non-pregnant female
- De novo lesions>70% or occlusions in the SFA (Superficial Femoral Artery) arteries suitable for stent angioplasty
- Max. 1 lesion within each leg should be treated as study lesions
- Lesions length range from ≥3 cm to ≤18 cm
Key exclusion criteria (31 listed)
- Patients for whom an anti-platelet therapy, anticoagulants or thrombolytics are contraindicated
- Patients presenting a lasting intraluminal thrombosis at the lesion after a thrombolytic therapy
- Perforation at the location of the angioplasty characterized by secretion of the contrast medium
- Aneurysm of the artery to be treated
- All common contraindications for a PTA (Percutaneous Transluminal Angioplasty)
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
Target lesion revascularization (TLR)
Time frame: 12 months
Target lesion revascularization (TLR) rate
21 secondary outcomes
Adverse Event
Time frame: 24 hours
Adverse Event
Time frame: 48 hours
Adverse Event
Time frame: 6 months
Adverse Event
Time frame: 12 months
Adverse Event
Time frame: 24 months
Technical success
Time frame: 24 hours
Procedural success
Time frame: 24 hours
Walking Impairment Questionnaire
Time frame: 6 months
Walking Impairment Questionnaire
Time frame: 12 months
Rutherford classification
Time frame: 48 hours
Rutherford classification
Time frame: 6 months
Rutherford classification
Time frame: 12 months
Rutherford classification
Time frame: 24 months
Health-related quality of life (SF-36 questionnaire)
Time frame: 12 months
Primary patency
Time frame: 6 months
Primary patency
Time frame: 12 months
Primary patency
Time frame: 24 months
Ankle brachial index (ABI)
Time frame: 48 hours
Ankle brachial index (ABI)
Time frame: 6 months
Ankle brachial index (ABI)
Time frame: 12 months
Ankle brachial index (ABI)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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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.
Michael Giese, Phd study chair
Eucatech AG
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Eucatech AG at 5 sites in 2 countries.
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 10 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Marx, MD (00497621167333 ext. 20, c.marx@clinical-evaluation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion revascularization (TLR) (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 11 Feb 2015.