Deep Vein ThrombosisP-MAXNCT03116750
Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT
An observational study of Deep Vein Thrombosis and Bypass Complication, run by Straub Medical AG at 9 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Bypass Complication, Dialysis Shunt
- How many people
- 81 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 3 Apr 2017to 6 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days)
- Age > 18 years
- Written informed consent form
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany4 sites
Universitätsklinikum Aachen
Aachen
Klinikum Arnsberg, Klinik für Angiologie
Arnsberg, 59755
Universitätsklinikum Heidelberg
Heidelberg
Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock
Rostock, 18057
Austria2 sites
Medizinische Universität Graz
Graz
Medizinische Universität Wien
Vienna
France1 site
CHU - Hôpital François-Mitterrand
Dijon, Bourgogne-Franche-Comté, 21079
About this study
Official 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
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.
- Keywords
- mechanical thrombectomy
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success (removal of occlusion and restoration of blood flow)
Primary patency
Measured: day of treatment
Secondary outcomes (9)
Adverse events
failure of usability
Measured: through study completion of 3 years
Adverse device effects
device related safety variables
Measured: through study completion of 3 years
Technical success rate
removal of occlusion
Measured: intraoperative
Swelling of limb
Circumference of the limb
Measured: through study completion of 3 years
Pain improvement
pain disability index
Measured: through study completion of 3 years
additional Treatment , acute
index treatment at index site
Measured: before 72 hours after treatment
additional Treatment, Long term
index treatment at index site
Measured: later than 72 hours after treatment
Hospital Stay
Duration of hospital stay
Measured: 4-5 days after treatment
Time to return back to ward
Treatment time
Measured: day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start3 Apr 2017
- Primary completion30 Dec 2021
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Straub Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116750
- Sponsor's protocol ID
- 15k013
- Acronym
- P-MAX
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2017
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03116750
- Acronym / sponsor ID
- P-MAX / 15k013
- Keywords
- mechanical thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Straub Medical AGIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days)
- Age > 18 years
- Written informed consent form
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural success (removal of occlusion and restoration of blood flow)
Time frame: day of treatment
Primary patency
9 secondary outcomes
Adverse events
Time frame: through study completion of 3 years
Adverse device effects
Time frame: through study completion of 3 years
Technical success rate
Time frame: intraoperative
Swelling of limb
Time frame: through study completion of 3 years
Pain improvement
Time frame: through study completion of 3 years
additional Treatment , acute
Time frame: before 72 hours after treatment
additional Treatment, Long term
Time frame: later than 72 hours after treatment
Hospital Stay
Time frame: 4-5 days after treatment
Time to return back to ward
Time frame: day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and Bypass Complication, run by Straub Medical AG at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria, France, Ireland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (removal of occlusion and restoration of blood flow) (time frame: day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.