- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02011984
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system (RECAM)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Baden Württemberg
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Freiburg, Baden Württemberg, Allemagne, 79095
- Recrutement
- Uniklinikum Freiburg, Abteilung Röntgendiagnostik
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Contact:
- Wulf Euringer, M.D.
- Numéro de téléphone: 38580 0049 761 270
- E-mail: wulf.euringer@uniklinik-freiburg.de
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Chercheur principal:
- Wulf Euringer, M.D.
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Hessen
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Marburg, Hessen, Allemagne, 35043
- Recrutement
- Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
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Contact:
- Mykhaylo Burbelko, M.D.
- Numéro de téléphone: 65912 0049 6421 58
- E-mail: burbelko@med.uni-marburg.de
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Chercheur principal:
- Mykhaylo Burbelko, M.D.
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Nordrhein - Westfalen
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Düsseldorf, Nordrhein - Westfalen, Allemagne, 40472
- Recrutement
- Augusta-Krankenhaus, Klinik für Gefäßchrirugie
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Contact:
- Ralf Kolvenbach, Prof.
- Numéro de téléphone: 301 0049 211 9043
- E-mail: kolvenbach@vkkd-kliniken.de
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Chercheur principal:
- Ralf Kolvenbach, Prof.
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Sachsen
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Zwickau, Sachsen, Allemagne, 08060
- Recrutement
- Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
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Contact:
- Jörg Thalwitzer, M.D.
- Numéro de téléphone: -4854/-4855 0049 375
- E-mail: irad@hbk-zwickau.de
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Chercheur principal:
- Jörg Thalwitzer, M.D.
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Lombardy
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Pavia, Lombardy, Italie, 27100
- Recrutement
- CCP - Istituto di Cura "Città di Pavia"
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Contact:
- Cesare Massa Saluzzo, M.D.
- Numéro de téléphone: 0039 3349419996
- E-mail: segreteria@centroendovascolare.it
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Chercheur principal:
- Cesare Massa Saluzzo, M.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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peripheral artery disease
de novo stenotic lesions in superficial femoral artery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Target lesion revascularization (TLR)
Délai: 12 months
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Target lesion revascularization (TLR) rate
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adverse Event
Délai: 24 hours
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Adverse Event rate
|
24 hours
|
Adverse Event
Délai: 48 hours
|
Adverse Event rate
|
48 hours
|
Adverse Event
Délai: 6 months
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Adverse Event rate
|
6 months
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Adverse Event
Délai: 12 months
|
Adverse Event rate
|
12 months
|
Adverse Event
Délai: 24 months
|
Adverse Event rate
|
24 months
|
Technical success
Délai: 24 hours
|
The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.
|
24 hours
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Procedural success
Délai: 24 hours
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Procedural success rate
|
24 hours
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Walking Impairment Questionnaire
Délai: 6 months
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Change from baseline in Walking Impairment Questionnaire scores
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6 months
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Walking Impairment Questionnaire
Délai: 12 months
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Change from baseline in Walking Impairment Questionnaire scores
|
12 months
|
Rutherford classification
Délai: 48 hours
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Change from baseline in Rutherford stage
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48 hours
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Rutherford classification
Délai: 6 months
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Change from baseline in Rutherford stage
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6 months
|
Rutherford classification
Délai: 12 months
|
Change from baseline in Rutherford stage
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12 months
|
Rutherford classification
Délai: 24 months
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Change from baseline in Rutherford stage
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24 months
|
Health-related quality of life (SF-36 questionnaire)
Délai: 12 months
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Change from baseline in health-related quality of life (SF-36 questionnaire scores)
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12 months
|
Primary patency
Délai: 6 months
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Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
6 months
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Primary patency
Délai: 12 months
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Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
12 months
|
Primary patency
Délai: 24 months
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Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
24 months
|
Ankle brachial index (ABI)
Délai: 48 hours
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Change from baseline in Ankle brachial index (ABI)
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48 hours
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Ankle brachial index (ABI)
Délai: 6 months
|
Change from baseline in Ankle brachial index (ABI)
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6 months
|
Ankle brachial index (ABI)
Délai: 12 months
|
Change from baseline in Ankle brachial index (ABI)
|
12 months
|
Ankle brachial index (ABI)
Délai: 24 months
|
Change from baseline in Ankle brachial index (ABI)
|
24 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Michael Giese, Phd, Eucatech AG
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- recam2013_eucatech
- ECT024ResiCSfaRegV10 (Autre identifiant: CERES)
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