Condition or disease | Intervention/treatment |
---|---|
Abdominal Aortic Aneurysms | Device: INCRAFT |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms |
Estimated Study Start Date : | August 31, 2019 |
Estimated Primary Completion Date : | August 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Group/Cohort | Intervention/treatment |
---|---|
INCRAFT
Endovascular abdominal aortic aneurysm repair
|
Device: INCRAFT
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.
|
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
The subject has one of the following conditions:
China | |
Beijing Anzhen Hospital | |
Beijing, China |
Principal Investigator: | Zhong Chen, Doctor | Beijing Anzhen Hospital |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date | May 15, 2019 | ||||||
First Posted Date | May 29, 2019 | ||||||
Last Update Posted Date | February 26, 2021 | ||||||
Estimated Study Start Date | August 31, 2019 | ||||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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.
|
||||||
Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
|
||||||
Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION) | ||||||
Official Title | A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms | ||||||
Brief 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. 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 Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
Target Follow-Up Duration | 1 Year | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients who are eligible for endovascular repair of an abdominal aortic aneurysm | ||||||
Condition | Abdominal Aortic Aneurysms | ||||||
Intervention | Device: INCRAFT
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 Groups/Cohorts | INCRAFT
Endovascular abdominal aortic aneurysm repair
Intervention: Device: INCRAFT
|
||||||
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 | Withdrawn | ||||||
Actual Enrollment |
0 | ||||||
Original Estimated Enrollment |
120 | ||||||
Estimated Study Completion Date | December 31, 2021 | ||||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03965364 | ||||||
Other Study ID Numbers | P18-0004 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement |
|
||||||
Responsible Party | Cordis Corporation | ||||||
Study Sponsor | Cordis Corporation | ||||||
Collaborators | Not Provided | ||||||
Investigators |
|
||||||
PRS Account | Cordis Corporation | ||||||
Verification Date | February 2021 |