AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029660
• Other study ID #: CRD 1029
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: June 2030

Study information

• Verified date: June 2024
• Source: Shape Memory Medical, Inc.
• Contact: Irene Kuhn
• Phone: 646-369-1591
• Email: ikuhn[@]namsa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2030
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age

2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm =5.5 cm in diameter in men and =5.0 cm in women;

3. Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA

4. Maximum Lumen diameter within the AAA sac of =40mm.

5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is =200.

Exclusion Criteria:

General

1. An inability to provide informed consent.

2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.

3. Unable or unwilling to comply with study follow-up requirements.

4. Prisoner or member of other vulnerable population

Anatomical

1. Concomitant iliac artery ectasia or aneurysm

2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.

3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.

4. Connective tissue disorder (e.g., Marfan's syndrome)

5. Aneurysmal disease of the descending thoracic aorta

6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties

EVAR/Procedural

1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA

2. Use of an aortic stent graft other than those specified1 for a particular site

3. Planned use of the chosen stent graft outside its instructions for use (IFU)

4. Use of fenestrated stent grafts or chimney techniques

5. Use of the Heli-FX EndoAnchor system

6. Use of embolic devices other than the investigational product to embolize the AAA sac

7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries

8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries

Medical History/Conditions

1. Coagulopathy or uncontrolled bleeding disorder

2. Serum creatinine level >2.5 mg/dL

3. Cerebrovascular accident within 3 months prior to the procedure

4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure

5. Atrial fibrillation that is not well rate controlled

6. Life expectancy of <2 years post-procedure

7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.

8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3)

9. A condition that inhibits radiographic visualization during the implantation procedure

10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.

11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial

12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• IMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants

Procedure:
• EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	ETZ Elisabeth	Tilburg
New Zealand	Auckland City Hospital	Auckland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Delray Medical Center	Delray Beach	Florida
United States	Corewell Health	Grand Rapids	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone	New York	New York
United States	Sentara Norfolk General	Norfolk	Virginia
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Honor Health	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Shape Memory Medical, Inc.	NAMSA

Countries where clinical trial is conducted

United States,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint : AAA Sac Regression at 1 year	The percentage of subjects showing regression, defined as sac volume reduction of =10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.	1 year
Primary	Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days	Freedom from the following through 30 days post-index procedure: Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL.; AAA-rupture or AAA-perforation; Conversion to Open Repair	30 days