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Registry to Compare the results between Surgical vs Balloon Angio

Registry to Compare the results between Surgical vs Balloon Angioplasty vs Intravascular Stent Placement for Recurrent or Native Coarctation of the Aorta.

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Cowden, Amanda

    Trial Phone: 321.841.5365

  • IRB No: 05.041.08

    Protocol Abbrev: COARCT

    Principal Investigator: David Gordon Nykanen, MD

    Sub Investigators: Decampli, William MD; Iacono, Karen ARNP; Schwartz, Matthew MD; Farias, Michael MD

    Age Group: Adult

    Secondary Protocol No: COARCT

    Applicable Disease Sites: Cardiology, Catheterization, Coarctation of the aorta

  • Objective

    The aims of the study is to compare results of surgical versus balloon angioplasty versus intravascular stent placement for immediate and intermediate outcomes in the treatment of isolated native or recurrent coarctation of the aorta. Our hypotheses is that intravascular stent placement will have superior success, both immediately and at intermediate follow up, in comparison to surgical repair or balloon angioplasty for the treatment of native or recurrent coarctation of the aorta.

  • Key Eligibility

    Inclusion criteria
    •  Patients greater than or equal to 10 kg body weight
    •  The presence of significant (> 20 mmHg systolic BP measurement from upper to lower extremity) in native or recurrent coarctation of the aorta; or the presence of decreased LV systolic function or aortic insufficiency in the presence of an upper to lower extremity BP gradient of greater than or equal to 10 mmHg; or <10 mm Hg gradient in the presence of significant collateral vessels or > 15mm Hg mean systolic gradient by Doppler interrogation.
    •  Standard treatment would include either surgical or transcatheter treatment of the coarctation segment.
    •  Patients with a known or suspected arteritis will be separately analyzed.
    •  Patients who do not require other surgical procedures that would entail
    correction of the coarctation segment in the same setting