Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT

NCT03116750 | Completed

• 1 other identifier: 15k013
• Study Type: observational
• Target: 81
• Locations: 5 countries
• Sites: 9

Brief Summary

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.

Conditions

Deep Vein Thrombosis; Bypass Complication; Dialysis Shunt; Stent Occlusion

Keywords

mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• Procedural success (removal of occlusion and restoration of blood flow)

  Primary patency

  day of treatment

Secondary Outcomes (9)

• Adverse events

  through study completion of 3 years

• Adverse device effects

  through study completion of 3 years

• Technical success rate

  intraoperative

• Swelling of limb

  through study completion of 3 years

• Pain improvement

  through study completion of 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Main study population: patients with DVT of the pelvis, legs and vena cava inferior. Additional patients with dialysis shunts and / or other bypasses, vena subclavia, vena brachiocephalica, vena cava superior, vena splenica and vena mesenterica superior/inferior will be included

You may qualify if:

• Acute thrombotic or thromboembolic occlusion (onset of pain \< 14 days)
• Age \> 18 years
• Written informed consent form

You may not qualify if:

• Patient not suitable for thrombectomy
• Fracture area of broken stents
• Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
• Persistent vasospasm
• Severe coagulatory disorders
• Patients with thrombophilia
• Aneurysmatically altered vessel segments on target zone or on passage of catheter
• Known or suspected infection, especially of the puncture site or the vessel segment being treated
• Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications
• Immature or not fully healed dialysis accesses or bypass grafts
• Female subjects of childbearing capacity who are not willing to employ contraceptive measures
• Pregnant or breast feeding subjects
• Subjects who are lawfully kept in an institution
• Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures
• Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening

Sponsors & Collaborators

• Straub Medical AG: lead

Study Sites (9)

Medizinische Universität Graz

Graz, Austria

Location

Medizinische Universität Wien

Vienna, Austria

Location

CHU - Hôpital François-Mitterrand

Dijon, Bourgogne-Franche-Comté, 21079, France

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

Klinikum Arnsberg, Klinik für Angiologie

Arnsberg, 59755, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock

Rostock, 18057, Germany

Location

Galway University Hospital

Galway, H91YR71, Ireland

Location

Azienda Ospedaliera San Giovanni Addolorata

Roma, Italy

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 17, 2017
• Study Start: April 3, 2017
• Primary Completion: December 30, 2021
• Study Completion: June 6, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); IE (1); FR (1); DE (4); IT (1)