4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / ANEUFIX for Endoleak Type II Repair

ANEUFIX for Endoleak Type II Repair

Study Description
Brief Summary:
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Endoleak Device: ANEUFIX Not Applicable

Detailed Description:

The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.

ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injection into the AAA-sac close to the nidus.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study evaluates the end-points in a total of 25 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
All patients enrolled are intended to be treated
Device: ANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.

Outcome Measures
Primary Outcome Measures :
  1. Technical success rate [ Time Frame: 24 hours ]
    Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the end of the procedure; presence or absence of endoleak is verified by means of CT scan at the end of or soon after the Aneufix injection procedure, i.e. within 24 hrs after the completion of the injection procedure.


Secondary Outcome Measures :
  1. Absence of aneurysm sac growth [ Time Frame: 3, 6 and 12 months ]
    Absence of aneurysm sac growth at 3, 6 and 12 months the end-point at 6 month is the ultimate clinical success rate assessment - growth is determined based on core lab assessments of lateral, frontal and/or longitudinal axis and/or largest diameters

  2. Intra- and peri-operative complications [ Time Frame: 30 days ]
    Documentation of intra- and peri-operative complications

  3. serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture [ Time Frame: During the Aneufix procedure ]
    Occurrence of serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture in the peri operative period.

  4. Occurrence of general adverse events and adverse device effects [ Time Frame: 1, 3, 6, 12 and 24 months ]
    Safety is assessed based on the nature and severity of observed adverse events

  5. Rate of re-interventions [ Time Frame: 1, 3, 6 and 12 months ]
    Rate of secondary endovascular or surgical re-interventions

  6. Rate of aneurysm rupture [ Time Frame: 6 and 12months ]
    Rate of aneurysm rupture will be observed

  7. Survival rate [ Time Frame: 24 months ]
    Survival throughout the study


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
  2. Volume of the 'endoleak void' can be estimated upfront; AND
  3. An EVAR without circulatory complications (including the absence of an open AMI as judged on existing CT-scan); AND
  4. An endoleak confirmed by CT scan in preceding 90 days demonstrating the high likelihood of the isolated nature of the endoleak; AND
  5. An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 90 days by means of Echo Doppler (or alternative visualization technique) and based upon sac diameter measurements; AND
  6. An aneurysm sac that can be punctured via a translumbar approach; AND
  7. Possibility to withhold anti-thrombogenic medication temporarily; AND
  8. Ability and willingness to undergo the translumbar procedure under local anesthaesia in a CT scanner; AND
  9. Being older than 18 years.

Exclusion Criteria:

  1. Patient not able or willing to give written Informed Consent; OR
  2. Patient undergoing emergency procedures; OR
  3. Patient with traumatic vascular injury; OR
  4. Patients with an untreated open endoleak connected AMI (patients can be included if the AMI is or is technically not possible to be coiled prior the Aneufix application); OR
  5. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
  6. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
  7. Patient who is allergic to contrast media or anticoagulants; OR
  8. Patient with renal impairment (eGFR < 30 ml/min); OR
  9. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
  10. Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
  11. Women of child-bearing potential, OR
  12. Patient with a life expectancy of less than 12 months.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Diedelinde Persijn, MSc +32471437477 dp@triumclinicalconsulting.com

Locations
Layout table for location information
Netherlands
Amsterdam UMC - VUmc Recruiting
Amsterdam, Netherlands
Contact: Arjan WJ Hoksbergen, Dr         
Sponsors and Collaborators
TripleMed B.V.
Trium Clinical Consulting
Investigators
Layout table for investigator information
Principal Investigator: Arjan WJ Hoksbergen, Dr VUmc Heelkunde, Amsterdam
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE May 13, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Technical success rate [ Time Frame: 24 hours ]
Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the end of the procedure; presence or absence of endoleak is verified by means of CT scan at the end of or soon after the Aneufix injection procedure, i.e. within 24 hrs after the completion of the injection procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
Technical success. [ Time Frame: 24 hours ]
Technical success of Type II endoleak repair with Aneufix ACP-T20 as demonstrated by the absence of an endoleak at the end of the procedure; presence of endoleak is verified by means of CT scan at the end of the ACP-T20 procedure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Absence of aneurysm sac growth [ Time Frame: 3, 6 and 12 months ]
    Absence of aneurysm sac growth at 3, 6 and 12 months the end-point at 6 month is the ultimate clinical success rate assessment - growth is determined based on core lab assessments of lateral, frontal and/or longitudinal axis and/or largest diameters
  • Intra- and peri-operative complications [ Time Frame: 30 days ]
    Documentation of intra- and peri-operative complications
  • serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture [ Time Frame: During the Aneufix procedure ]
    Occurrence of serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture in the peri operative period.
  • Occurrence of general adverse events and adverse device effects [ Time Frame: 1, 3, 6, 12 and 24 months ]
    Safety is assessed based on the nature and severity of observed adverse events
  • Rate of re-interventions [ Time Frame: 1, 3, 6 and 12 months ]
    Rate of secondary endovascular or surgical re-interventions
  • Rate of aneurysm rupture [ Time Frame: 6 and 12months ]
    Rate of aneurysm rupture will be observed
  • Survival rate [ Time Frame: 24 months ]
    Survival throughout the study
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Intraoperative occurrence of complications; [ Time Frame: 24 hours ]
    The serious adverse events occurring during the surgical intervention are registered.
  • Serious adverse events, [ Time Frame: 1, 3, 6 and 12 month ]
    Vascular related adverse events and adverse device effects;
  • Clinical success rate. [ Time Frame: 3, 6 and 12 months ]
    Absence of aneurysm sac growth at 3, 6 and 12 months, measured by the aneurysm sac diameter on CT scans (clinical success rate at 6 months is the ultimate end-point assessment)
  • Peri-operative complications. [ Time Frame: 30 days ]
    Rate of peri-operative complications
  • Re-interventions. [ Time Frame: 1, 3, 6 and 12 months ]
    Rate of secondary endovascular or surgical re-interventions
  • Aneurysm rupture [ Time Frame: 6 and 12months ]
    Rate of aneurysm rupture
  • Survival [ Time Frame: 24 months ]
    Survival throughout the study
  • General safety [ Time Frame: 24 months ]
    Safety is assessed based on the nature and severity of observed adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANEUFIX for Endoleak Type II Repair
Official Title  ICMJE Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
Brief Summary The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.
Detailed Description

The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.

ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injection into the AAA-sac close to the nidus.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study evaluates the end-points in a total of 25 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Aortic Aneurysm
  • Endoleak
Intervention  ICMJE Device: ANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
Study Arms  ICMJE Experimental: Intervention
All patients enrolled are intended to be treated
Intervention: Device: ANEUFIX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
  2. Volume of the 'endoleak void' can be estimated upfront; AND
  3. An EVAR without circulatory complications (including the absence of an open AMI as judged on existing CT-scan); AND
  4. An endoleak confirmed by CT scan in preceding 90 days demonstrating the high likelihood of the isolated nature of the endoleak; AND
  5. An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 90 days by means of Echo Doppler (or alternative visualization technique) and based upon sac diameter measurements; AND
  6. An aneurysm sac that can be punctured via a translumbar approach; AND
  7. Possibility to withhold anti-thrombogenic medication temporarily; AND
  8. Ability and willingness to undergo the translumbar procedure under local anesthaesia in a CT scanner; AND
  9. Being older than 18 years.

Exclusion Criteria:

  1. Patient not able or willing to give written Informed Consent; OR
  2. Patient undergoing emergency procedures; OR
  3. Patient with traumatic vascular injury; OR
  4. Patients with an untreated open endoleak connected AMI (patients can be included if the AMI is or is technically not possible to be coiled prior the Aneufix application); OR
  5. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
  6. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
  7. Patient who is allergic to contrast media or anticoagulants; OR
  8. Patient with renal impairment (eGFR < 30 ml/min); OR
  9. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
  10. Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
  11. Women of child-bearing potential, OR
  12. Patient with a life expectancy of less than 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diedelinde Persijn, MSc +32471437477 dp@triumclinicalconsulting.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918460
Other Study ID Numbers  ICMJE TripleMed 002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TripleMed B.V.
Study Sponsor  ICMJE TripleMed B.V.
Collaborators  ICMJE Trium Clinical Consulting
Investigators  ICMJE
Principal Investigator: Arjan WJ Hoksbergen, Dr VUmc Heelkunde, Amsterdam
PRS Account TripleMed B.V.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP