An interventional study of Large Diameter Advanta™ V12 Covered Stent in Coarctation of the Aorta, sponsored by Atrium Medical Corporation. Completed at 9 sites in 7 countries. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Atrium Medical Corporation · Not applicable, Interventional, and Treatment
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 70 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Atrium Medical Corporation is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of Large Diameter Advanta™ V12 Covered Stent.
Device: Large Diameter Advanta™ V12 Covered Stent
Stent placement
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).
Time frame: 12 month
Primary Safety
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Time frame: 30 days of procedure
Secondary Safety
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)
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.
Time frame: 12 month
Secondary Safety
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Time frame: 12 months
Plan to share: Undecided
The record gives a start of Sep 2009, a primary completion of May 2013 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Atrium Medical Corporation