HemorrhageOCCLUDE-IINCT02033954
Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding
An observational study of Hemorrhage and Bleeding, run by ArtVentive Medical Group, Inc. at 7 sites in 3 countries.
Trial summary
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhage, Bleeding
- How many people
- 40 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2014to Jan 2016
- How long will I take part?
- 30 Days
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects requiring permanent occlusion of the peripheral vessels for the following conditions: 1. Stopping blood loss from a damaged blood vessel from a traumatic vascular injury 2. Hemorrhage caused by a neoplasia 3. Neoplastic process (tumor) 4. Gastrointestinal bleeding 5. Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula 6. Interrupting blood supply to an organ or part of an organ for permanent devascularization 7. Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure. 8. Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Who may be able to join
- Subjects aged ≥18 to ≤75 years.
- Subject with target vessels of 3.0 mm to 12 mm in diameter.
- Subject is able and willing to comply with all study requirements, including the required study follow-up visits.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form. In the event of emergency procedure and subject and/or legal representative is unable to provide consent prior to study enrollment, consent will be obtained at earliest possible time following procedure for consent to continue to participate in the study.
Who cannot join
- Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
- Subjects in whom venography or arteriography is contraindicated.
- Subjects with known hypersensitivity or contraindication to nickel or nitinol.
- Subject is pregnant or breastfeeding.
- Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites, 4 recruiting
- Not yet recruiting
Universitatsklinikum Carl Gustav Carus Institut
Dresden
Ralf Hoffmann, PD Dr., +49 351 - 458 2259, radiologie@uniklinikum--dresden.de
Ralf Hoffmann, PD Dr.
- Not yet recruiting
Universität Leipzig - Department für Bildgebung und Strahlenmedizin
Leipzig
Michael Moche, Dr., +49 341 9717558, Michael.moche@medizin.uni-leipzig.de
- Not yet recruiting
Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
Marburg
Andreas Mahnken, Prof Dr, +49 6421 58-66231, m.treitl@med.unimuenchen.de
Andreas Mahnken, Prof Dr
- Not yet recruiting
LMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie
Munich
Marcus Treitl, Prof dr, +49 89-5160-9271, m.treitl@med.unimuenchen.de
Marcus Treitl, Prof Dr
Austria2 sites, 2 recruiting
- Recruiting
Klinikum Klagenfurt am Worthersee
Klagenfurt
Klaus Hausegger, Prof. Dr., +43 463 538 38 503, Klaus.hausegger@kabeg.at
- Not yet recruiting
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz
Peter Waldenberger, Prof Dr, +43 73276777346, Peter.waldenberger@bhs.at
Peter Waldenberger, Prof Dr
Belgium1 site, 1 recruiting
- Not yet recruiting
UZ Leuven
Leuven
Geert Maleux, Prof Dr, +32 16 34 37 82, geert.maleux@uzleuven.be
Geert Maleux, Prof Dr
About this study
Official title: PrOspective, MultiCenter Study for the Evaluation of PerformanCe of the ArtVentive Medical Group Peripheral EndoLuminal OcclUsion SystemTM for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding - OCCLUDE II
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
Read the detailed description
Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:
- Stopping blood loss from a damaged blood vessel from a traumatic vascular injury
- Hemorrhage caused by a neoplasia
- Neoplastic process (tumor)
- Gastrointestinal bleeding
- Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula
- Interrupting blood supply to an organ or part of an organ for permanent devascularization
- Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure
- Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Conditions
- Hemorrhage, Bleeding
- Keywords
- Embolization, Hemorrhage, TIPS, GI Bleeding, AV Fistula, AV Malformation, Traumatic Vascular Injury
- Medical subject headings
- Hemorrhage, Gastrointestinal Hemorrhage, Arteriovenous Fistula, Arteriovenous Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plague distal to the device) at 30 days.
Measured: Acute & 30 days
Secondary outcomes (1)
Occlusion
Sustained occlusion at 30 days follow-up.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- ArtVentive Medical Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Mahnken, Prof Dr, Principal investigator, Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033954
- Sponsor's protocol ID
- TD 0088 / 04
- Acronym
- OCCLUDE-II
- Status last verified
- Jun 2015
- First submitted
- 8 Jan 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.
PubMed 23703667
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOspective, MultiCenter Study for the Evaluation of PerformanCe of the ArtVentive Medical Group Peripheral EndoLuminal OcclUsion SystemTM for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding - OCCLUDE II
- ClinicalTrials.gov ID
- NCT02033954
- Acronym / sponsor ID
- OCCLUDE-II / TD 0088 / 04
- Conditions
- Hemorrhage, Bleeding
- Keywords
- Embolization, Hemorrhage, TIPS, GI Bleeding, AV Fistula, AV Malformation, Traumatic Vascular Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ArtVentive Medical Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- 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.
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
Detailed description
Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:
- Stopping blood loss from a damaged blood vessel from a traumatic vascular injury
- Hemorrhage caused by a neoplasia
- Neoplastic process (tumor)
- Gastrointestinal bleeding
- Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula
- Interrupting blood supply to an organ or part of an organ for permanent devascularization
- Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure
- Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring permanent occlusion of the peripheral vessels for the following conditions: 1. Stopping blood loss from a damaged blood vessel from a traumatic vascular injury 2. Hemorrhage caused by a neoplasia 3. Neoplastic process (tumor) 4. Gastrointestinal bleeding 5. Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula 6. Interrupting blood supply to an organ or part of an organ for permanent devascularization 7. Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure. 8. Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Key inclusion criteria (4 listed)
- Subjects aged ≥18 to ≤75 years.
- Subject with target vessels of 3.0 mm to 12 mm in diameter.
- Subject is able and willing to comply with all study requirements, including the required study follow-up visits.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form. In the event of emergency procedure and subject and/or legal representative is unable to provide consent prior to study enrollment, consent will be obtained at earliest possible time following procedure for consent to continue to participate in the study.
Key exclusion criteria (5 listed)
- Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
- Subjects in whom venography or arteriography is contraindicated.
- Subjects with known hypersensitivity or contraindication to nickel or nitinol.
- Subject is pregnant or breastfeeding.
- Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
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
Safety
Time frame: Acute & 30 days
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plague distal to the device) at 30 days.
1 secondary outcome
Occlusion
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 23703667Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.
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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.
Andreas Mahnken, Prof Dr principal investigator
Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Bleeding, run by ArtVentive Medical Group, Inc. at 7 sites in 3 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leon Rudakov, PhD (+1 (760) 471-7700, leonrudakov@artventivemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Acute & 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033954, which also lists 1 linked publication.
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 24 Jun 2015.