Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Coarctation of the Aorta Clinical Trial

Official title:

Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978952
• Other study ID #: 803
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: June 29, 2017
• Start date: September 2009
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Atrium Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.

Description:

The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand [1]. The CCISC experience from 1989 to 2005 shows a true procedural success rate of 98.6%.

The patient population will be subjects with coarctation of the aorta. A total of 70 subjects, children, adolescents and adults, will be enrolled at up to 15 study sites. Baseline clinical and angiographic assessment will determine the subject's eligibility for enrollment in the study. Subjects will continue in the study for long term annual follow-up through 3, 4, and 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2017
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography.

• Subject weighs a minimum of 30 kg.

• The peak pressure gradient is =20 mmHg systolic blood pressure across the coarctation site.

• Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon.

• Coarctation can be successfully crossed with a guide wire, sheath and device.

• Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter.

• Subject is able and willing to adhere to all required follow-up visits and testing.

• Subject is able and willing to adhere to the required follow-up medication regimen.

Exclusion Criteria:

• The physician is not able to access the coarctation with standard techniques.

• Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure.

• Length of coarctation is greater than 45 mm in length.

• Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome.

• The coarctation has adjacent, acute thrombus.

• The coarctation was previously treated with a stent.

• Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta™ V12 Covered Stent device (e.g. "jailing" of the branch vessel).

• Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta™ V12 Covered Stent

• Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.

• Bloodstream infection

• Subject is pregnant or breastfeeding.

• Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.

• The investigator deems the subject to be an inappropriate candidate for the study.

• Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of the Aorta

Intervention

Device:
• Large Diameter Advanta™ V12 Covered Stent
Stent placement

Locations

Country	Name	City	State
Australia	The Children's Hospital at Westmead	Sydney
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Canada	Hospital for Sick Children Labatt Family Heart Centre	Toronto	Ontario
Germany	Heart Institute Berlin	Berlin
Germany	CardioVascular Center	Frankfurt
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin
Israel	Schneider Children's Medical Center	Petach Tikva
Italy	San Donato Hospital	Milan
United Kingdom	Bristol Royal Hospital for Children and Bristol Royal Infirmary	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Atrium Medical Corporation

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Germany,  Israel,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy	The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).	12 month
Primary	Primary Safety	30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)	30 days of procedure
Secondary	Secondary Safety	Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.	procedural (time zero)
Secondary	Secondary Safety	No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.	12 month
Secondary	Secondary Safety	Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)	12 months