Trial record 4 of 13 for:    "Aortic coarctation"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT00978952
First received: September 14, 2009
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Coarctation of the Aorta
Device: Large Diameter Advanta™ V12 Covered Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Resource links provided by NLM:


Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • Primary Efficacy [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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).

  • Primary Safety [ Time Frame: 30 days of procedure ] [ Designated as safety issue: Yes ]
    30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)


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

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

  • Secondary Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)


Enrollment: 70
Study Start Date: September 2009
Estimated Study Completion Date: May 2017
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Large Diameter Advanta™ V12 Covered Stent
    Stent placement
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978952

Locations
Australia
The Children's Hospital at Westmead
Sydney, Australia, 2145
Brazil
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
Germany
Heart Institute Berlin
Berlin, Germany
CardioVascular Center
Frankfurt, Germany, 60389
Asklepios Klinik Sankt Augustin
Sankt Augustin, Germany, 53757
Israel
Schneider Children's Medical Center
Petach Tikva, Israel
Italy
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
Investigators
Principal Investigator: Elchanan Bruckheimer, MD Schneider Children's Medical Center, Israel
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00978952     History of Changes
Other Study ID Numbers: 803
Study First Received: September 14, 2009
Last Updated: May 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: German Institute of Medical Documentation and Information
Italy: Ministry of Health
Brazil: National Committee of Ethics in Research
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 21, 2014