DEFIANCE - Comparison of the ClotTriever System and Treatment with Anticoagulant Medications
Descrizione riassuntiva dello studio
The purpose of this clinical study is to compare 2 types of treatment for deep vein thrombosis. A deep vein thrombosis is a blood clot in a blood vessel (a vein) of the leg that disrupts or blocks blood flow in the vessel and needs to be treated to avoid serious consequences. This study compares two methods for treating such deep vein thrombosis. The treatment methods to be compared in this study are: 1. ClotTriever procedure plus anticoagulant medication (‘blood thinner’) 2. Anticoagulant medication (‘blood thinner’) alone. Both treatment methods will be compared at the end of the study, and it will be examined which of the two methods is more effective in treating deep vein thrombosis. Each patient participating in this study will be randomly assigned to one of the two treatment options. Once the random decision is made, the physician will inform the patient of the assignment to the respective treatment method. The ClotTriever thrombectomy system (referred to as “ClotTriever”) is a small medical device for treating deep vein thrombosis in the leg. The ClotTriever is introduced through an access in the groin into the affected blood vessel, up to the point where the blood clot is located. The blood clot is then captured with the ClotTriever and subsequently pulled out of the blood vessel. Anticoagulant medications are a group of medications that reduce the blood's ability to clot to prevent new blood clots from forming. These medications are often colloquially referred to as “blood thinners.” Within this study, the patient will be treated either with ClotTriever + anticoagulant medications or with anticoagulant medications alone.
(BASEC)
Intervento studiato
The following two treatment methods will be compared: 1. ClotTriever procedure plus anticoagulant medication (‘blood thinner’) 2. Anticoagulant medication (‘blood thinner’) alone. In the treatment with ClotTriever, the ClotTriever thrombectomy system, a small device for treating deep vein thrombosis in the leg, is introduced into the affected blood vessel, up to the point where the blood clot is located. The blood clot is then captured with the ClotTriever and subsequently pulled out of the blood vessel. This treatment method is combined with the use of anticoagulant medications. In the second treatment arm, only anticoagulant medications are used.
(BASEC)
Malattie studiate
Deep vein thrombosis of the leg
(BASEC)
1. Age ≥ 18 years 2. Unilateral thrombosis of the lower extremities 3. Onset of symptoms within 12 weeks prior to enrollment in the study (BASEC)
Criteri di esclusione
2. Previous venous stent in the target venous segment 4. Presence of an IVC filter at the time of enrollment in the study 5. Threatening impairment of limb circulation (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
Inari Medical Europe GmbH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Bart Rijckaert
+49 176 382 351 62
bart.rijckaert@clutterredeoptimus.comRede Optimus Hospitalar AG
(BASEC)
Informazioni generali
MedStar Health Research Institution,Henry Ford Health,St Thomas' Hospital (UK),
6027992920
christine.wills@inarimedical.com(ICTRP)
Informazioni generali
MedStar Health Research InstitutionHenry Ford HealthSt Thomas' Hospital (UK)
6027992920
christine.wills@inarimedical.com(ICTRP)
Informazioni generali
MedStar Health Research InstitutionHenry Ford HealthSt Thomas' Hospital (UK)
602-578-0738
kevin.wilhelmi@stryker.com(ICTRP)
Informazioni scientifiche
MedStar Health Research Institution,Henry Ford Health,St Thomas' Hospital (UK),
6027992920
christine.wills@inarimedical.com(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
08.09.2023
(BASEC)
ID di studio ICTRP
NCT05701917 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
DEFIANCE - Randomized controlled trial of ClotTriever system versus anticoagulation in deep vein thrombosis (BASEC)
Titolo accademico
DEFIANCE - ClotTriever Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis (ICTRP)
Titolo pubblico
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (ICTRP)
Malattie studiate
Venous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome (ICTRP)
Intervento studiato
Device: ClotTriever SystemDrug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria
- Age >= 18 years
- Proximal lower extremity unilateral DVT involving at least the common femoral,
external iliac, or common iliac veins, alone or in combination
- Symptom onset within 12 weeks of enrollment in the study
- Significant symptoms, as defined by a Villalta score > 9
- Willing and able to provide informed consent
Exclusion Criteria
- Bilateral iliofemoral DVT
- Prior venous stent in the target venous segment
- IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac
veins
- IVC filter in place at the time of enrollment
- Limb-threatening circulatory compromise (e.g., phlegmasia)
- Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC
from the CIV
- Symptomatic PE with right heart strain where the physician judges that a DVT
intervention is inappropriate at this time.
- Inability to be a candidate for intervention due to medical or technical reasons
based on physician judgement
- Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
- Severe allergy to iodinated contrast agents that cannot be mitigated
- Hemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets <
50,000/l which cannot be corrected prior to enrollment
- Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on
dialysis
- Inability to provide therapeutic anticoagulation per Investigator discretion
- Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or
diastolic > 105mmHg)
- Recently (< 30 days) had DVT interventional procedure
- Subject is participating in another study that may interfere with this study
- Life expectancy < 6 months or chronic non-ambulatory status
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be
medically managed throughout the study period
- Subject has any condition for which, in the opinion of the Investigator,
participation would not be in the best interest of the subject (e.g.,
contraindication to use of ClotTriever per local approved labeling, compromise the
well-being or that could prevent, limit, or confound the protocol-specified
assessments)
- Subject has previously completed or withdrawn from this study
- Patient unwilling or unable to conduct the follow up visits per protocol (ICTRP)
non disponibile
Endpoint primari e secondari
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: (ICTRP)
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:;Assessment of PTS Severity: (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Steven Abramowitz, MD;Xhorlina Marko, MD;Stephen Black, MD;Christine Wills, christine.wills@inarimedical.com, 6027992920, MedStar Health Research Institution,Henry Ford Health,St Thomas' Hospital (UK), (ICTRP)
ID secondari
22-001 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05701917 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile