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

NCT01664078 | Completed Results DMC

• 1 other identifier: P11-4601
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

  30 days post-procedure

• 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.

  Up to 1 year post-procedure

Secondary Outcomes (9)

• Procedure-related Complications

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

• Aneurysm-related Mortality

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

• Incidence of Secondary Interventions

  through 5 years

• Major Adverse Events (MAEs) and Individual Components of the MAEs

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

• Device-related Events

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

Other Outcomes (2)

• Pain Post-Operatively

  Baseline, 1 month, 6 months and 1 year post-procedure

• Physical Functioning Post-operatively

  Screening, 1 month, 6 months and 1 year post-procedure

Study Arms (1)

InCraft® - AAA stent graft system

EXPERIMENTAL

Intervention: Endovascular AAA repair using the InCraft device

Device: Endovascular AAA repair with InCraft®

Interventions

Endovascular AAA repair with InCraft® DEVICE

InCraft® - AAA stent graft system

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead
• Carelon Research: collaborator
• Quintiles, Inc.: collaborator

Study Sites (2)

Michel S. Makaroun, MD

Pittsburgh, Pennsylvania, 15217, United States

Location

Takao Ohki, MD

Minato-ku, Tokyo, 105-8461, Japan

Location

Related Publications (1)

• 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.

  PMID: 30879790 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

Number of participants at risk my vary depending on varying windows used for analysis, imaging availability, visits completed and will therefore not be consistent throughout report.

Results Point of Contact

• Title: Jennifer Lee
• Organization: Cordis US Corp

jennifer.lee02@cordis.com

+1-669-699-6851

Study Officials

• Michel S Makaroun, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Takao Ohki, MD

  Jikei University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 14, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 10, 2018
• Last Updated: July 3, 2024
• Results First Posted: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); US (1)