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Abdominal Aortic AneurysmINSPIRATIONNCT01664078

A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

A study testing Endovascular AAA repair with InCraft® in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Endovascular AAA repair with InCraft®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
2 sitesin 2 countries
Study dates
Jul 2012to 10 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must meet ALL of the following inclusion criteria to be enrolled in the study:
  • Male or Female age 20 years or older;
  • Proximal aortic neck is 17-31mm in diameter;
  • Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used;
  • Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°;
  • Subject has at least one of the following:
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  • AAA size > 5.0 cm;
  • Increase of the AAA diameter of > 0.5 cm over the last 6 months;
  • Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm;
  • Aortic bifurcation >18mm in diameter;
  • Iliac landing zone ≥15mm in length;
  • Iliac landing zone 7-22mm in diameter;
  • Minimum access vessel size of ≥ 5mm;
  • Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm;
  • Women of child bearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure;
  • Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures;
  • Willing to comply with the specified follow-up evaluation schedule.

Who cannot join

  • Subjects will be excluded if ANY of the following exclusion criteria apply:
  • Vascular anatomy in which the placement of the stent-graft will cause occlusion of both internal iliac arteries or necessitates surgical occlusion of both internal iliac arteries;
  • Subject has one of the following:
  • Aneurysm sac rupture or leaking abdominal aortic aneurysm;
  • Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
  • Clinically significant acute vascular injury due to trauma;
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  • Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device;
  • A conical aortic neck defined as >3mm distal increase over a 10mm length in the planned seal zone;
  • Thoracic aortic aneurysm ≥45mm;
  • Any aortic dissection;
  • Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta;
  • Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis;
  • Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE);
  • Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated);
  • Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);
  • Coagulopathy, bleeding disorder, or other hypercoagulable state;
  • Organ transplant recipient or subject requiring systemic immunosuppressant therapy;
  • Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure;
  • Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives;
  • Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards;
  • Co-existing condition with a life expectancy of less than 2 years at time of procedure;
  • Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
  • Existing AAA surgical graft and/or a AAA stent-graft system;
  • Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Michel S. Makaroun, MD

    Pittsburgh, Pennsylvania, 15217

Other trials in United States

Japan1 site

  • Takao Ohki, MD

    Minato-ku, Tokyo, 105-8461

Other trials in Japan

About this study

The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.

Read the detailed description

In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths. The most significant complication of AAA is an aneurysm sac rupture from which more than 15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm repair (EVAR) and open surgical repair cases were performed in the year 2010 .

Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an alternative treatment of AAA for most patients. It is less invasive than open repair and carries lower rates of early mortality and morbidity . It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk. As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the aortic neck and access vessels.

The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, which assists the physician in deploying the device in a controlled, consistent, and precise manner within the aortic neck and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture.

Being tested
Endovascular AAA repair with InCraft®
Keywords
Abdominal Aortic Aneurysm
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.

  • Endovascular AAA repair with InCraft®Device

Study groups in NCT01664078
Study groupRoleWhat they receive
InCraft® - AAA stent graft systemExperimentalIntervention: Endovascular AAA repair using the InCraft device
Receives: Device: Endovascular AAA repair with InCraft®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate

    defined as a composite of:

    • Death
    • Stroke
    • Myocardial Infarction
    • New Onset Renal Failure (requiring dialysis)
    • Respiratory Failure (requires mechanical ventilation)
    • Paralysis/paraparesis
    • Bowel ischemia (requiring surgical intervention)
    • Procedural blood loss ≥1,000 cc

    Measured: 30 days post-procedure

  2. Number of Participants With Successful Aneurysm Treatment

    Successful aneurysm treatment which is a composite endpoint of the following:

    • Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;
    • Absence of post-operative aneurysm enlargement (growth > 5 mm) or stent graft migration (> 10mm) compared to the one month size measurement at anytime up to 1-year;
    • Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.

    Measured: Up to 1 year post-procedure

Secondary outcomes (9)

  1. Procedure-related Complications

    Adverse events that are a result of the procedure itself.

    Measured: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure

  2. Aneurysm-related Mortality

    Measured: At 30-days, 180-days, 360-days and annually to 5-years post-procedure

  3. Incidence of Secondary Interventions

    The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.

    Measured: through 5 years

  4. Major Adverse Events (MAEs) and Individual Components of the MAEs

    Measured: At 180-days, 360-days and annually to 5-years post-procedure

  5. Device-related Events

    Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.

    Measured: At 1 month, 6 months, 1 year and annually to 5-years post-procedure

  6. Technical Success Confirmed by CT or Other Imaging Modality

    The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.

    Measured: At 30-days

  7. Length of Hospital Stay (Days) Post Index Procedure

    Measured: up to 17 days

  8. Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure

    Measured: up to 48 hours

  9. Length of the Index Procedure (Minutes)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completion10 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01664078
Sponsor's protocol ID
P11-4601
Acronym
INSPIRATION
Status last verified
Aug 2020
First submitted
9 Aug 2012
Last updated
3 Jul 2024
Data monitoring committee
Yes
Individual data sharing
No
Expanded access
Available

Publications

  • Iantorno M, Buchanan KD, Bernardo NL, Torguson R, Waksman R. Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System. Cardiovasc Revasc Med. 2019 May;20(5):403-408. doi: 10.1016/j.carrev.2019.02.018. Epub 2019 Feb 18.

    PubMed 30879790

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular AAA repair with InCraft® in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. at 2 sites in 2 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 17 inclusion and 24 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Japan. 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?

Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. 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 NCT01664078, 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 3 Jul 2024.

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