A Multicenter, Open Label, Prospective, Non-randomized St... | NCT01664078

Name	Class
Carelon Research	OTHER
Quintiles, Inc.	INDUSTRY

Description Module

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.

Label	Type	Description	Intervention Names
InCraft® - AAA stent graft system	Experimental	Intervention: Endovascular AAA repair using the InCraft device	Device: Endovascular AAA repair with InCraft®

Name	Type	Description	Arm Group Labels	Other Names
Endovascular AAA repair with InCraft®	Device		InCraft® - AAA stent graft system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Procedure-related Complications	Adverse events that are a result of the procedure itself.	Through 1 month, 180-days, 360-days and annually to 5-years post-procedure
Aneurysm-related Mortality

Other Outcomes

Measure	Description	Time Frame
Pain Post-Operatively	Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.	Baseline, 1 month, 6 months and 1 year post-procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must meet ALL of the following inclusion criteria to be enrolled in the study:
1. Male or Female age 20 years or older;
2. Proximal aortic neck is 17-31mm in diameter;
3. Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used;
4. Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°;
5. Subject has at least one of the following:
  1. AAA size > 5.0 cm;
  2. Increase of the AAA diameter of > 0.5 cm over the last 6 months;
6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm;
7. Aortic bifurcation >18mm in diameter;
8. Iliac landing zone ≥15mm in length;
9. Iliac landing zone 7-22mm in diameter;
10. Minimum access vessel size of ≥ 5mm;
11. Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm;
12. 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;
13. Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures;
14. Willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

Subjects will be excluded if ANY of the following exclusion criteria apply:
1. 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;
2. Subject has one of the following:
  1. Aneurysm sac rupture or leaking abdominal aortic aneurysm;
  2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
  3. Clinically significant acute vascular injury due to trauma;
3. Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device;
4. A conical aortic neck defined as >3mm distal increase over a 10mm length in the planned seal zone;
5. Thoracic aortic aneurysm ≥45mm;
6. Any aortic dissection;
7. Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta;
8. Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis;
9. Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE);
10. Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated);
11. Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);
12. Coagulopathy, bleeding disorder, or other hypercoagulable state;
13. Organ transplant recipient or subject requiring systemic immunosuppressant therapy;
14. Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure;
15. Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives;
16. Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards;
17. Co-existing condition with a life expectancy of less than 2 years at time of procedure;
18. Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
19. Existing AAA surgical graft and/or a AAA stent-graft system;
20. 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.

Name	Affiliation	Role
Michel S Makaroun, MD	University of Pittsburgh	Principal Investigator
Takao Ohki, MD	Jikei University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Michel S. Makaroun, MD		Pittsburgh	Pennsylvania	15217	United States
Takao Ohki, MD

PubMed Identifier	Type	Citation	Retractions
30879790	Derived	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.

ID	Title	Description
FG000	InCraft® - AAA Stent Graft System	Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®

ID	Title	Description
BG000	InCraft® - AAA Stent Graft System	Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®

Units	Counts
Participants	BG000190

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Count of Participants

Participants

30 days post-procedure

ID	Title	Description
OG000	InCraft® - AAA Stent Graft System	Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®

Units	Counts
Participants	OG000183

Title

Denominators

Categories

Title	Measurements
	OG00020

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Mixed Models Analysis		0.47														Other	The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.

Primary

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.

Posted

Count of Participants

Participants

Up to 1 year post-procedure

ID	Title	Description
OG000	InCraft® - AAA Stent Graft System	Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®

Units	Counts
Participants	OG000

Secondary

Procedure-related Complications

Adverse events that are a result of the procedure itself.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Site-reported Procedure-related AEs Through 1 Month	procedure-related complications were tabulated as secondary safety endpoints
OG001	Site-reported Procedure-related AEs Through 180 Days	procedure-related complications were tabulated as secondary safety endpoints
OG002	Site-reported Procedure-related AEs Through 360 Days	procedure-related complications were tabulated as secondary safety endpoints
OG003	Site-reported Procedure-related AEs Through 2 Years	procedure-related complications were tabulated as secondary safety endpoints
OG004	Site-reported Procedure-related AEs Through 3 Years

Secondary

Aneurysm-related Mortality

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Aneurysm-related Morality Through 1 Month	Aneurysm-related mortality is defined as 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.
OG001	Aneurysm-related Morality Through 180 Days	Aneurysm-related mortality is defined as 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.
OG002	Aneurysm-related Morality Through 360 Days	Aneurysm-related mortality is defined as 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.
OG003	Aneurysm-related Morality Through 2 Years	Aneurysm-related mortality is defined as 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.

Secondary

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.

Posted

Count of Participants

Participants

through 5 years

ID	Title	Description
OG000	Secondary Intervention Through 1 Month	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.
OG001	Secondary Intervention Through 180 Days	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.
OG002	Secondary Intervention Through 360 Days	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.

Secondary

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	MAEs Through 180 Days	All MAEs are site-reported then adjudicated by the CEC.
OG001	MAEs Through 360 Days	All MAEs are site-reported then adjudicated by the CEC.
OG002	MAEs Through 2 Years	All MAEs are site-reported then adjudicated by the CEC.
OG003	MAEs Through 3 Years	All MAEs are site-reported then adjudicated by the CEC.
OG004	MAEs Through 4 Years	All MAEs are site-reported then adjudicated by the CEC.
OG005	MAEs Through 5 Years

Secondary

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Device-related Events Through 1 Month	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.
OG001	Device-related Events Through 180 Days	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.

Secondary

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.

Posted

Count of Participants

Participants

At 30-days

ID	Title	Description
OG000	Technical Success	Technical success confirmed by CT or other imaging modality

Units	Counts
Participants	OG000188

Secondary

Length of Hospital Stay (Days) Post Index Procedure

Posted

Mean

Standard Deviation

days

up to 17 days

ID	Title	Description
OG000	Length of Hospital Stay (Days) Post Index Procedure	Length of hospital stay (days) post index procedure as part of the clinical utility measure

Units	Counts
Participants	OG000190

Title	Denominators	Categories

Secondary

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

Posted

Mean

95% Confidence Interval

hours

up to 48 hours

ID	Title	Description
OG000	Length of Intensive Care Unit (ICU) Stay (Hours) Post Index pr	Length of Intensive Care Unit (ICU) stay (hours) post index pr as part of the clinical utility measure

Units	Counts
Participants	OG000190

Title	Denominators	Categories

Secondary

Length of the Index Procedure (Minutes)

Posted

Mean

95% Confidence Interval

minutes

1 day

ID	Title	Description
OG000	Length of the Index Procedure (Minutes)	Length of the Index Procedure (Minutes) as part of the clinical utility measure

Units	Counts
Participants	OG000190

Title	Denominators	Categories

Other Pre-specified

Pain Post-Operatively

Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Posted

Mean

95% Confidence Interval

Units on a Scale

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

ID	Title	Description
OG000	Pain Post-Operatively at Baseline	Pain post-operatively as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
OG001	Pain Post-Operatively at 1-Month	Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
OG002	Pain Post-Operatively at 6-Months	Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up
OG003	Pain Post-Operatively at 1-Year

Other Pre-specified

Physical Functioning Post-operatively

Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Posted

Mean

95% Confidence Interval

Units on a Scale

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

ID	Title	Description
OG000	Physical Functioning Post-operatively at Baseline	Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
OG001	Physical Functioning Post-operatively at 1 Month	Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up
OG002	Physical Functioning Post-operatively at 6 Month	Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiac disorders	Cardiac disorders	Systematic Assessment	EG00015 affected188 at risk
Congenital disorders	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected188 at risk
Gastrointestinal disorders	Gastrointestinal disorders	Systematic Assessment	EG0005 affected188 at risk
General disorders and administration site conditions	General disorders	Systematic Assessment	EG0007 affected188 at risk
Infections and infestations	Infections and infestations	Systematic Assessment	EG0002 affected188 at risk
Injury, poisoning and procedural complications2	Injury, poisoning and procedural complications	Systematic Assessment	EG0006 affected188 at risk
Investigations	Investigations	Systematic Assessment	EG0001 affected188 at risk
Neoplasms benign, malignant and unspecified (including cysts and polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0006 affected188 at risk
Nervous system disorders	Nervous system disorders	Systematic Assessment	EG0009 affected188 at risk
Renal and urinary disorders	Renal and urinary disorders	Systematic Assessment	EG0001 affected188 at risk
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected188 at risk
Vascular disorders	Vascular disorders	Systematic Assessment	EG0009 affected188 at risk
Blood and Lymphatic	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected188 at risk
Metabolisms and Nutrition Disorders	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected188 at risk
Surgical and medical procedures	Surgical and medical procedures	Systematic Assessment	EG0002 affected188 at risk

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases