- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978952
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sydney, Australia, 2145
- The Children's Hospital at Westmead
-
-
-
-
-
Sao Paulo, Brazil, 04012-180
- Instituto Dante Pazzanese de Cardiologia
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children Labatt Family Heart Centre
-
-
-
-
-
Berlin, Germany
- Heart Institute Berlin
-
Frankfurt, Germany, 60389
- Cardiovascular Center
-
Sankt Augustin, Germany, 53757
- Asklepios Klinik Sankt Augustin
-
-
-
-
-
Petach Tikva, Israel
- Schneider Children's Medical Center
-
-
-
-
-
Milan, Italy
- San Donato Hospital
-
-
-
-
-
Bristol, United Kingdom, BS2 8BJ
- Bristol Royal Hospital for Children and Bristol Royal Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Group
Use of Large Diameter Advanta™ V12 Covered Stent.
|
Stent placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 month
|
Primary Safety
Time Frame: 30 days of procedure
|
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
|
30 days of procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
procedural (time zero)
|
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.
|
12 month
|
Secondary Safety
Time Frame: 12 months
|
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elchanan Bruckheimer, MD, Schneider Children's Medical Center, Israel
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coarctation of the Aorta
-
Alexandria UniversityCompletedMitral Regurgitation | Cardiac Septal Defects With Coarctation of the AortaEgypt
-
Richard E. RingelCompleted
-
University Children's Hospital, ZurichUnknownTetralogy of Fallot | Transposition of the Great Arteries | Coarctation of the AortaSwitzerland
-
University of California, San FranciscoAmerican Heart AssociationTerminatedCoarctation of the AortaUnited States
-
Boston Children's HospitalEnrolling by invitationCoarctation of the Aorta | Aortic Arch ObstructionUnited States
-
Children's Healthcare of AtlantaTerminatedDiagnosis of Coarctation of the Aorta and VSD | Surgical Repair at CHOA | Between January 1, 2002 and December 31, 2005United States
-
Hospices Civils de LyonCompleted
-
Datascope Corp.UnknownAneurysmal Disease of the Abdominal Aorta | Occlusive Disease of the Abdominal AortaFrance
-
University of Wisconsin, MadisonMeriter FoundationRecruiting
Clinical Trials on Large Diameter Advanta™ V12 Covered Stent
-
Helsinki University Central HospitalActive, not recruitingChronic Pancreatitis | Biliary StrictureFinland
-
Erasmus Medical CenterActive, not recruitingNecrosis | Arteriosclerosis | Stenosis | Lifestyle-related Condition | Gastrointestinal Vascular Conditions | Vascular InsufficiencyNetherlands
-
Boston Scientific CorporationCompleted
-
Boston Scientific CorporationCompletedBiliary Strictures Caused by Malignant NeoplasmsItaly, Belgium, France, Germany, India, Netherlands
-
Boston Scientific CorporationCompletedRefractory Benign Esophageal Strictures Caused by Caustic IngestionIndia
-
C. R. BardCompletedPeripheral Vascular Disease | Peripheral Artery Disease | Arterial Occlusive DiseaseUnited States, Germany, New Zealand
-
Boston Scientific CorporationCompletedCholestasis, ExtrahepaticUnited States
-
Boston Scientific CorporationCompletedPancreatic CancerUnited States, Korea, Republic of, Belgium, Italy, Japan, Canada
-
Boston Scientific CorporationCompletedPancreatic CarcinomaAustralia, France, Japan, Belgium, Hong Kong, Italy, China, India, United States
-
Samsung Medical CenterTaewoong Medical Co., Ltd.UnknownUreteral ObstructionKorea, Republic of