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

NCT00978952 | Completed DMC

• 1 other identifier: 803
• Study Type: interventional
• Target: 70
• Locations: 7 countries
• Sites: 9

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.

Conditions

Coarctation of the Aorta

Outcome Measures

Primary Outcomes (2)

• 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 Safety

  30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)

  30 days of procedure

Secondary Outcomes (3)

• Secondary Safety

  procedural (time zero)

• Secondary Safety

  12 month

• Secondary Safety

  12 months

Study Arms (1)

Investigational Group

EXPERIMENTAL

Use of Large Diameter Advanta™ V12 Covered Stent.

Device: Large Diameter Advanta™ V12 Covered Stent

Interventions

Large Diameter Advanta™ V12 Covered Stent DEVICE

Stent placement

Investigational Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (9)

The Children's Hospital at Westmead

Sydney, 2145, Australia

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-180, Brazil

Location

Hospital for Sick Children Labatt Family Heart Centre

Toronto, Ontario, M5G 1X8, Canada

Location

Heart Institute Berlin

Berlin, Germany

Location

CardioVascular Center

Frankfurt, 60389, Germany

Location

Asklepios Klinik Sankt Augustin

Sankt Augustin, 53757, Germany

Location

Schneider Children's Medical Center

Petah Tikva, Israel

Location

San Donato Hospital

Milan, Italy

Location

Bristol Royal Hospital for Children and Bristol Royal Infirmary

Bristol, BS2 8BJ, United Kingdom

Location

Related Publications (1)

• Bruckheimer E, Birk E, Benson L, Butera G, Martin R, Roberts PA, Schneider MBE, Schubert S, Sievert H, Pedra CCA. Large Diameter Advanta V12 Covered Stent Trial for Coarctation of the Aorta: COARC Study. Circ Cardiovasc Interv. 2021 Dec;14(12):e010576. doi: 10.1161/CIRCINTERVENTIONS.121.010576. Epub 2021 Nov 9.

  PMID: 34749516 DERIVED

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elchanan Bruckheimer, MD

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

AU (1); BR (1); CA (1); IL (1); GB (1); DE (3); IT (1)