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

Primary Purpose

Coarctation of the Aorta

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Large Diameter Advanta™ V12 Covered Stent
Sponsored by
Atrium Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coarctation of the Aorta

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Children's Hospital at Westmead
  • Instituto Dante Pazzanese de Cardiologia
  • Hospital for Sick Children Labatt Family Heart Centre
  • Heart Institute Berlin
  • CardioVascular Center
  • Asklepios Klinik Sankt Augustin
  • Schneider Children's Medical Center
  • San Donato Hospital
  • Bristol Royal Hospital for Children and Bristol Royal Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Group

Arm Description

Use of Large Diameter Advanta™ V12 Covered Stent.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Safety
Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
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.
Secondary Safety
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)

Full Information

First Posted
September 14, 2009
Last Updated
June 29, 2017
Sponsor
Atrium Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00978952
Brief Title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Official Title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atrium Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coarctation of the Aorta

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Group
Arm Type
Experimental
Arm Description
Use of Large Diameter Advanta™ V12 Covered Stent.
Intervention Type
Device
Intervention Name(s)
Large Diameter Advanta™ V12 Covered Stent
Intervention Description
Stent placement
Primary Outcome Measure Information:
Title
Primary Efficacy
Description
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).
Time Frame
12 month
Title
Primary Safety
Description
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Time Frame
30 days of procedure
Secondary Outcome Measure Information:
Title
Secondary Safety
Description
Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Time Frame
procedural (time zero)
Title
Secondary Safety
Description
No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
Time Frame
12 month
Title
Secondary Safety
Description
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elchanan Bruckheimer, MD
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital at Westmead
City
Sydney
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
Hospital for Sick Children Labatt Family Heart Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Heart Institute Berlin
City
Berlin
Country
Germany
Facility Name
CardioVascular Center
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Asklepios Klinik Sankt Augustin
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Facility Name
Schneider Children's Medical Center
City
Petach Tikva
Country
Israel
Facility Name
San Donato Hospital
City
Milan
Country
Italy
Facility Name
Bristol Royal Hospital for Children and Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34749516
Citation
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. Erratum In: Circ Cardiovasc Interv. 2022 Jul;15(7):e000087.
Results Reference
derived

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

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