Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
NCT06652568
Cardiovascular Diseases, Deep Vein Thrombosis
New York, United States
View Trial DetailsNCT Number: NCT03116750
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.
CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.
ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.
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Notify Me18 year and older
All sexes
Observational
Medizinische Universität Graz, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: day of treatment
Primary patency
Time frame: through study completion of 3 years
failure of usability
Time frame: through study completion of 3 years
device related safety variables
Time frame: intraoperative
removal of occlusion
Time frame: through study completion of 3 years
Circumference of the limb
Time frame: through study completion of 3 years
pain disability index
Time frame: before 72 hours after treatment
index treatment at index site
Time frame: later than 72 hours after treatment
index treatment at index site
Time frame: 4-5 days after treatment
Duration of hospital stay
Time frame: day of treatment
Treatment time
Straub Medical AG
Industry
Post-Market Clinical Follow-up Study with the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups
Acronym: P-MAX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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