Trial document




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  DRKS00006303

Trial Description

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Title

Osypka BabyStent® for the treatment of aortic isthmus stenosis in early childhood

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Trial Acronym

Osypka BabyStent® trial

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URL of the Trial

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Brief Summary in Lay Language

Open surgery or balloon dilatation were the only treatments of aortic isthmus stenosis in children in their first year of life open surgery. This is due to the fact that the arteries of a child are too small for implantation of a stent for adults and blood vessels could be damaged. Currently, there are no CE marked stents available for babies and young children.

The new Osypka BabyStent® can be delivered via the small groin blood vessels of the child, will grow into the aortic tissue and will remain at this position for the child's entire life.

The aim of this clinical trial is to show the successful implantation of the Osypka BabyStent®. This would result in a minimally invasive treatment option (=heart catheter where no open surgery is needed) for children suffering from aortic isthmus stenosis.

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Brief Summary in Scientific Language

Prospective, open, one-armed, multicentric interventional clinical trial to assess performance and safety of the Osypka BabyStent® in the treatment of aortic isthmus stenosis in children not older than two years.

If a balloon dilatation is not sufficient, children will be eligible for implantation of the Osypka BabyStent.

All further assessments and the follow-up will be performed according to clinical routine after balloon dilatation.

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Organizational Data

  •   DRKS00006303
  •   2014/12/19
  •   [---]*
  •   yes
  •   Approved
  •   368/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   CIV-14-08-012499 
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Health Condition or Problem studied

  •   Q25.1 -  Coarctation of aorta
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Interventions/Observational Groups

  •   Implantation of Osypka BabyStent(R)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Successful implantation defined as implantation in target area and > 50% increase of inner diameter of stenosis compared to inital inner diameter of stenosis, measured by angiography immediately after stent implantation.

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Secondary Outcome

- Pressure gradient at stent area after 4 weeks, 3, 6 and 12 months, measured by Doppler echocardiography.
- Numbers of re-interventions up to 12 months after implantation
- Access vessel patency after 3 months (Doppler sonography)
- Chest X-Ray after 3 months: integrity of stent struts
- Optional: in individual cases re-dilatation of stent by balloon angioplasty and bursting of stent with balloon (12 mm balloon diameter)
- Safety endpoints: adverse events, vital signs
- Total duration of follow-up: 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/10
  •   19
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Weeks
  •   2   Years
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Additional Inclusion Criteria

1. Patients with stenosis of the aortic isthmus/aortic arch with an inner diameter of the stenosis of 0 to 5 mm requiring treatment
2. Patients from 0 to 24 months of age
3. Body weight from 1.8 to 20 kg
4. Height from 40 to 100 cm
5. Written consent of parents or legal guardian available
6. Patients for whom no further surgical treatment options are available, defined as
a. Children who have developed an early re-stenosis after coarctation (CoA) surgery, or
b. Children who have developed a re-stenosis after complex aortic arch surgery, in particular children with hypoplastic left heart syndrome following stage 1 Norwood procedure, children with surgical correction of an interrupted aortic arch or previous surgery of aortic arch hypoplasia, or
c. High-risk patients with limited treatment options other than stent implantation, e.g. children with VACTERL association, oesophageal atresia and thoracic fistula, or
d. Neonates with a severe complex congenital malformation syndrome with life-threatening heart failure due to CoA who require acute treatment prior to final diagnosis (e.g., children with suspected trisomy 18 or 13 with a short life expectancy in the medium term and for whom major surgery is not reasonable).
7. An individual, interdisciplinary consultation has taken place and has been documented in writing in which the paediatric cardiologist as well as the paediatric heart surgeon has considered the catheter-driven intervention (balloon and stent) as a favourable treatment for the patient as compared to open surgery. If, based on the judgment of the treating interventionalist during cardiac catheterisation, a simple balloon angioplasty is considered as insufficient for treating the residual gradient and/or residual stenosis according to the pathology of the underlying heart defect, the Osypka BabyStent® is to be implanted. (This requires a case-by-case decision since the acceptable residual gradient varies for different concomitant heart defects.)

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Exclusion Criteria

1. Body weight < 1.8 kg or > 20 kg
Note: Children with a body weight below 1.8 kg are excluded from this trial since it is unclear whether the growth-related size of the afferent blood vessels is adequate for the use of the required 4-French sheath
2. Sepsis
3. Lack of written consent of parents or legal guardian
4. Lack of interdisciplinary consultation
5. Lack of consent of paediatric cardiac surgeon to interventional procedure
6. Surgical treatment (surgery) is successful for the treatment of the CoA
7. Following balloon dilatation the residual gradient and/or residual stenosis is small enough to consider the treatment as successful even if no stent was placed
8. Cardiac diseases:
a. In case the smallest part of the CoA is above 5 mm, or
b. In case there is an aneurysm adjacent to the implantation site, or
c. Patients requiring surgery due to their concomitant cardiac defect in whom the CoA is well accessible to the surgeon during surgery (e.g., stage 1 Norwood procedure for hypoplastic left heart syndrome), or
d. Patients with very long stenoses, severe calcifications or a diffuse disease, i.e. with multiple stenoses.
9. Non-cardiac anomalies:
a. In case it is not possible to access the location of the lesion by means of common placing techniques, in particular by using a transport sheath
b. Patients with a contraindication to treatment with heparin or aspirin
10. Any other contraindications to cardiac catheterisation, e.g.,
a. Acute infectious diseases or childhood diseases like e.g., measles, varicella, pertussis
b. Severe coagulation disorders (e.g., disseminated intravascular coagulation (DIC))
11. Emergency procedures in which the criteria 3 to 5 have not been fulfilled within an adequate interval prior to the start of cardiac catheterisation.
12. Incompatibility of the reference diameter of the vessel to be treated with the size of the stent. In particular no stent must be placed in vessels with a stenosis diameter of more than 6 mm (maximum size of the balloon).

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Addresses

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    • Universitäts Herzzentrum Freiburg Bad KrozingenKlinik für Angeborene Herzfehler und Pädiatrische Kardiologie
    • Ms.  Prof. Dr. med.  Brigitte  Stiller 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Universitäts Herzzentrum Freiburg Bad KrozingenKlinik für Angeborene Herzfehler und Pädiatrische Kardiologie
    • Ms.  Prof. Dr. med.  Brigitte  Stiller 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Universitäts Herzzentrum Freiburg Bad KrozingenKlinik für Angeborene Herzfehler und Pädiatrische Kardiologie
    • Ms.  Prof. Dr. med.  Brigitte  Stiller 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Peter-Osypka-Stiftung
    • Hornrain 31
    • 79639  Grenzach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/10
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Trial Publications, Results and other Documents

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