Post-Market Clinical Follow-up Study With ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT (P-MAX)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Deep Vein Thrombosis; Bypass Complication; Dialysis Shunt; Stent Occlusion

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medizinische Universität Graz
  • Wien, Austria
    • Medizinische Universität Wien
• France
  • Bourgogne/Franche-Comté
    • Dijon, Bourgogne/Franche-Comté, France, 21079
      • CHU - Hôpital François-Mitterrand
• Germany
  • Aachen, Germany
    • Universitätsklinikum Aachen
  • Arnsberg, Germany, 59755
    • Klinikum Arnsberg, Klinik für Angiologie
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Rostock, Germany, 18057
    • Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock
• Ireland
  • Galway, Ireland, H91YR71
    • Galway University Hospital
• Italy
  • Roma, Italy
    • Azienda Ospedaliera San Giovanni Addolorata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days)
2. Age > 18 years
3. Written informed consent form

Exclusion Criteria:

1. Patient not suitable for thrombectomy
2. Fracture area of broken stents
3. 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
4. Persistent vasospasm
5. Severe coagulatory disorders
6. Patients with thrombophilia
7. Aneurysmatically altered vessel segments on target zone or on passage of catheter
8. Known or suspected infection, especially of the puncture site or the vessel segment being treated
9. Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications
10. Immature or not fully healed dialysis accesses or bypass grafts
11. Female subjects of childbearing capacity who are not willing to employ contraceptive measures
12. Pregnant or breast feeding subjects
13. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study
14. Subjects who are lawfully kept in an institution
15. Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures
16. Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success (removal of occlusion and restoration of blood flow)	Primary patency	day of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	failure of usability	through study completion of 3 years
Adverse device effects	device related safety variables	through study completion of 3 years
Technical success rate	removal of occlusion	intraoperative
Swelling of limb	Circumference of the limb	through study completion of 3 years
Pain improvement	pain disability index	through study completion of 3 years
additional Treatment , acute	index treatment at index site	before 72 hours after treatment
additional Treatment, Long term	index treatment at index site	later than 72 hours after treatment
Hospital Stay	Duration of hospital stay	4-5 days after treatment
Time to return back to ward	Treatment time	day of treatment

Collaborators and Investigators

• Sponsor: Straub Medical AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2017
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (ACTUAL): April 17, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: mechanical thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 15k013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No