Abdominal Aortic AneurysmsNCT03965364
China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
An observational study of Abdominal Aortic Aneurysms, run by Cordis US Corp. at 1 site in China.
Trial summary
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- INCRAFT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2019to 31 Dec 2021
- How long will I take part?
- 1 Year
- 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: Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Who may be able to join
- Male or female aged 18 and over
- The femoral access vessel is adequate for the selected delivery system;
- Length of proximal aneurysmal neck ≥ 10mm;
- Aortic neck diameter ≥ 17mm and ≤ 31mm;
- The aortic neck is suitable for suprarenal fixation;
- The angle of the infrarenal and suprarenal neck is ≤60 degrees;
Show all 12Show fewer
- Iliac fixation length ≥ 15mm;
- Iliac diameter ≥ 7mm and ≤ 22mm;
- Minimum total AAA treatment length (proximal landing point to distal landing point) ≥ 128mm;
- Morphology is suitable for aneurysm repair;
- Written informed consent form shall be provided prior to initiating any study protocol;
- The subject is willing to follow the prescribed follow-up schedule.
Who cannot join
- The subject has one of the following conditions:
- Aneurysm sac rupture or leaking abdominal aortic aneurysm
- Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
- Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE);
- Known contraindication to undergoing angiography or anticoagulation
- Existing AAA surgical graft and/or a AAA stent-graft system;
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
Read the detailed description
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- INCRAFT
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCRAFTDevice
Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.
| Study group | Role | What they receive |
|---|---|---|
| INCRAFT | Endovascular abdominal aortic aneurysm repair Receives: Device: INCRAFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of major adverse events
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Measured: Within 30-days post-procedure
Secondary outcomes (7)
Occurence of major adverse events
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Measured: Through 1 year post-procedure
Technical success
The technical success at the end of the first surgery, which was defined as the successful insertion of the delivery system and the successful placement of the device at the desired location.
Measured: At the conclusion of the index procedure
Absence of stent graft migration(>10mm)
Stent graft migration is defined as evidence of proximal or distal movement of the stent graft > 10mm relative to fixed anatomical landmarks compared with the 1 month size measurement.
Measured: Assessed at 1 year
Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)
Endoleak is defined as a persistent blood flow outside the lumen of the endoluminal graft but within an aneurysm sac or adjacent vascular segment being treated by the device. They are the result of incomplete sealing, or exclusion of the aneurysm sac, and thus cause reflux of blood flow into the sac.
Aneurysm enlargement is defined as an increase in maximum aneurysm cross sectional diameter greater than 5mm compared to a baseline measurement, or any subsequent measurement following baseline.
Measured: Assessed at 1 year compared to size measurement at 1 month
Absence of stent graft fracture
Stent-graft fracture is defined as stent skeleton fracture and barb separation.
Measured: Assessed within 30-days and 1-year post-procedure
Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture
Stent occlusion is defined as a complete absence of flow, within the AAA stent graft (aortic bifurcate or one or both iliac limbs).
Measured: Within 1-year post-procedure
Absence of all-cause mortality and aneurysms-related death
Aneurysms-related death is defined as a death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair or death from any subsequent procedure required to treat the same aneurysm.
Measured: Within 1-year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start31 Aug 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: due to lack of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhong Chen, Doctor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965364
- Sponsor's protocol ID
- P18-0004
- Status last verified
- Feb 2021
- First submitted
- 15 May 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03965364
- Acronym / sponsor ID
- P18-0004
- Conditions
- Abdominal Aortic Aneurysms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 May 2019 (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.
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
Detailed description
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCRAFT | – | Device: INCRAFTEndovascular abdominal aortic aneurysm repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Key inclusion criteria (12 listed)
- Male or female aged 18 and over
- The femoral access vessel is adequate for the selected delivery system;
- Length of proximal aneurysmal neck ≥ 10mm;
- Aortic neck diameter ≥ 17mm and ≤ 31mm;
- The aortic neck is suitable for suprarenal fixation;
Key exclusion criteria (7 listed)
- The subject has one of the following conditions:
- Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE);
- Known contraindication to undergoing angiography or anticoagulation
- Existing AAA surgical graft and/or a AAA stent-graft system;
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCRAFTDevice: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System. | Device | INCRAFT |
Primary outcome
Absence of major adverse events
Time frame: Within 30-days post-procedure
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
7 secondary outcomes
Occurence of major adverse events
Time frame: Through 1 year post-procedure
Technical success
Time frame: At the conclusion of the index procedure
Absence of stent graft migration(>10mm)
Time frame: Assessed at 1 year
Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)
Time frame: Assessed at 1 year compared to size measurement at 1 month
Absence of stent graft fracture
Time frame: Assessed within 30-days and 1-year post-procedure
Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture
Time frame: Within 1-year post-procedure
Absence of all-cause mortality and aneurysms-related death
Time frame: Within 1-year post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zhong Chen, Doctor principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by Cordis US Corp. at 1 site in China.
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 12 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Absence of major adverse events (time frame: Within 30-days post-procedure). 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 26 Feb 2021.