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Completed

NCT Number: NCT03116750

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study
  • 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

Treatment and study plan

Primary outcomes

  1. Procedural success (removal of occlusion and restoration of blood flow)

    Time frame: day of treatment

    Primary patency

Secondary outcomes

  1. Adverse events

    Time frame: through study completion of 3 years

    failure of usability

  2. Adverse device effects

    Time frame: through study completion of 3 years

    device related safety variables

  3. Technical success rate

    Time frame: intraoperative

    removal of occlusion

  4. Swelling of limb

    Time frame: through study completion of 3 years

    Circumference of the limb

  5. Pain improvement

    Time frame: through study completion of 3 years

    pain disability index

  6. additional Treatment , acute

    Time frame: before 72 hours after treatment

    index treatment at index site

  7. additional Treatment, Long term

    Time frame: later than 72 hours after treatment

    index treatment at index site

  8. Hospital Stay

    Time frame: 4-5 days after treatment

    Duration of hospital stay

  9. Time to return back to ward

    Time frame: day of treatment

    Treatment time

Sponsors and collaborators

Lead sponsor

Straub Medical AG

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
Apr 17, 2017
Registry last updated
Dec 3, 2024

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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