The STAPLE International Post-Market Registry

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

The STAPLE-International Post-Market Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01276249
• Other study ID #: CD03335-01
• Status: Terminated
• Start date: August 2010
• Est. completion date: June 19, 2015

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

Description:

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects. All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: June 19, 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient = 18 years old

2. Patient has given written informed consent

3. Patient has a life expectancy > 1 year

4. Patient is willing to comply with follow-up evaluations

5. Patient's AAA meets at least one of the following criteria:

• = 4.5cm in diameter
• Increased in size by 0.5cm in last 6 months
• Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
• Saccular aneurysm larger than 3cm in maximal diameter

6. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm

7. Patient has a proximal aortic neck length of at least 12mm

8. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.

9. Patient has bilateral iliac artery distal fixation site = 10mm in length with an internal diameter between 9mm and 20mm

Exclusion Criteria:

1. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results

2. Patient has a symptomatic AAA

3. Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm

4. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition

5. Patient has aortic mural pathology that is = 2mm in thickness over = 50% of the circumference of the proximal fixation site

6. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition

7. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)

8. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aorto Iliac Aneurysm
• Iliac Aneurysm

Intervention

Device:
• Fortevo Endograft
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.

Locations

Country	Name	City	State
Canada	Sherbrooke University Hospital Centre	Sherbrooke	Quebec
Germany	German Heart Center	Berlin
Germany	Cardiovascular Center Frankfurt	Frankfurt
Germany	St. Bonifatious Hospital	Lingen
Greece	Hellenic Airforce Hospital	Athens
Italy	University of Siena	Siena
Netherlands	St Antonious Hospital	Nieuwegein
Spain	Thorax Institute Hospital Clinic	Barcelona
Spain	University of Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Canada,  Germany,  Greece,  Italy,  Netherlands,  Spain, 

References & Publications (2)

Deaton DH, Mehta M, Kasirajan K, Chaikof E, Farber M, Glickman MH, Neville RF, Fairman RM. The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year. J Vasc Surg. 2009 Apr;49(4):851-7; discussion 857- — View Citation

Deaton DH. Future technologies to address the failed endoprosthesis. Semin Vasc Surg. 2009 Jun;22(2):111-8. doi: 10.1053/j.semvascsurg.2009.04.010. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success	The first primary endpoint is primary technical success. It consists of the following items: Successful arterial access; Successful deployment of the Fortevo Endograft with secure proximal and distal fixation; Absence of type I or III endoleaks; Patent Fortevo Endograft without significant twist, kinking, or obstruction	Within 24 hours of the Index procedure
Primary	Major Adverse Events (MAE)	The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events: Death; Myocardial Infarction; Stroke (excludes TIA); Renal failure (excludes renal insufficiency); Respiratory Failure (excludes COPD or pulmonary complications); Paralysis (excludes paraparesis)	Within 1-Month of Implantation
Secondary	Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components	Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of: Death as a result of aneurysm-related treatment; Type I or III endoleak; Fortevo Endograft infection; Fortevo Endograft thrombosis; Fortevo Endograft dilatation by 20% or more in diameter; Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M; Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity; Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M; Aneurysm rupture; Conversion to open repair	1-Month, 6-Months and 12-Months