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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978952
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Atrium Medical Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Coarctation of the Aorta Device: Large Diameter Advanta™ V12 Covered Stent Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Study Start Date : September 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Investigational Group
Use of Large Diameter Advanta™ V12 Covered Stent.
Device: Large Diameter Advanta™ V12 Covered Stent
Stent placement

Primary Outcome Measures :
  1. Primary Efficacy [ Time Frame: 12 month ]
    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).

  2. Primary Safety [ Time Frame: 30 days of procedure ]
    30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)

Secondary Outcome Measures :
  1. Secondary Safety [ Time Frame: procedural (time zero) ]
    Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.

  2. Secondary Safety [ Time Frame: 12 month ]
    No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.

  3. Secondary Safety [ Time Frame: 12 months ]
    Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00978952

The Children's Hospital at Westmead
Sydney, Australia, 2145
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil, 04012-180
Canada, Ontario
Hospital for Sick Children Labatt Family Heart Centre
Toronto, Ontario, Canada, M5G 1X8
Heart Institute Berlin
Berlin, Germany
CardioVascular Center
Frankfurt, Germany, 60389
Asklepios Klinik Sankt Augustin
Sankt Augustin, Germany, 53757
Schneider Children's Medical Center
Petach Tikva, Israel
San Donato Hospital
Milan, Italy
United Kingdom
Bristol Royal Hospital for Children and Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Atrium Medical Corporation
Principal Investigator: Elchanan Bruckheimer, MD Schneider Children's Medical Center, Israel

Responsible Party: Atrium Medical Corporation Identifier: NCT00978952     History of Changes
Other Study ID Numbers: 803
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities