Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding

Bleeding Clinical Trial

— OCCLUDE-II  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02033954
• Other study ID #: TD 0088 / 04
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: June 22, 2015
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: ArtVentive Medical Group, Inc.
• Contact: Leon Rudakov, PhD
• Phone: +1 (760) 471-7700
• Email: leonrudakov[@]artventivemedical.com
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionGermany: Ethics CommissionBelgium: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.

Description:

Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects aged =18 to =75 years.

2. Subject with target vessels of 3.0 mm to 12 mm in diameter.

3. Subject is able and willing to comply with all study requirements, including the required study follow-up visits.

4. 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.

Exclusion Criteria:

1. Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.

2. Subjects in whom venography or arteriography is contraindicated.

3. Subjects with known hypersensitivity or contraindication to nickel or nitinol.

4. Subject is pregnant or breastfeeding.

5. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Worthersee	Klagenfurt
Austria	Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.	Linz
Belgium	UZ Leuven	Leuven
Germany	Universitatsklinikum Carl Gustav Carus Institut	Dresden
Germany	Universität Leipzig - Department für Bildgebung und Strahlenmedizin	Leipzig
Germany	Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und	Marburg
Germany	LMU Klinikum der Universität München, Campus Innenstadt, Interventionelle Radiologie	Munich

Sponsors (1)

Lead Sponsor	Collaborator
ArtVentive Medical Group, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Acute & 30 days	Yes
Secondary	Occlusion	Sustained occlusion at 30 days follow-up.	30 days	Yes