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APERTO CVS PMCF Study (APERTO CVS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514406
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborators:
CliPS Service
OPIS srl
Information provided by (Responsible Party):
Cardionovum GmbH

Study Description
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Brief Summary:
Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients

Condition or disease Intervention/treatment
Dialysis; Complications Central Vein Obstruction Stenosis Restenosis Device: APERTO OTW DCB

Detailed Description:

The APERTO CVS PMCF study is aimed to evaluate safety and effectiveness of treatment of central veins (re)stenosis in dialysis patients at short and mid-term follow up, after treatment with APERTO OTW DCB. Primary endpoint will consist in evaluating the intervention free period for patients treated with APERTO OTW.

APERTO CVS PMCF Study will also collect data for post-market clinical follow up (PMCF) in a CE mark device used according to intended use

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Group/Cohort Intervention/treatment
APERTO OTW DCB
Dialysis patients treated with APERTO OTW following (re)stenosis of central veins
 Device: APERTO OTW DCB
Drug Coated Balloon Angioplasty


Outcome Measures
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Primary Outcome Measures :
  1. Clinically Assessed Intervention free period at 6 months fup [ Time Frame: 6 months ]
    clinically assessed intervention free period at 6 months (IFP) defined as dialysis access circuit with no need for clinically driven target lesion repeat intervention for symptom recurrence


Secondary Outcome Measures :
  1. Procedural Technical Success [ Time Frame: intraoperative ]
    Residual stenosis is no more than 30% after treatment with APERTO OTW measured by angiography

  2. Procedural Clinical Success [ Time Frame: intraoperative ]
    After the procedure, haemodialysis access function improved, dialysis function restored, and at least one dialysis session completed

  3. Procedural Surgical Success [ Time Frame: intraoperative ]
    On the basis of technical success, no major adverse events (MAE) occurred during hospitalization or treatment

  4. Major Adverse Event [ Time Frame: 12 months follow up ]
    include death, stroke, thrombosis, allergic reactions, and pulmonary diseases (including pulmonary edema), bleeding complication with the need of transfusion

  5. Fistula Flow [ Time Frame: 6 months ]
    Flow measured with Echo Doppler measured at 6 months

  6. Recirculation Rate [ Time Frame: 6 months ]
    Recirculation rate measured at 6 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Dialysis patients with symptoms for stenosis or restenosis of central veins to be treated with percutaneous angioplasty.
Criteria

Inclusion Criteria:

  • Patients age >18, no pregnant women, able to perform fup visits, life expectancy > 12 months
  • Dialysis patients undergoing endovascular angioplasty due to clinically symptomatic stenosis (de novo or restenosis) of the central veins with significant (>50%) stenosis and diameter
  • The target lesion consists of one or more lesions with a target lesion length of less than or equal to 100 mm
  • The target blood vessel diameter of the target lesion is between 6.0 and 16.0 mm (in angiographic or ultrasound evaluation);
  • If there are other non-target lesions, then non-target lesions must be successfully cured with a not drug coated balloon before treating the target lesion;

Exclusion Criteria:

  • Patients with CVS observed and estimated as nonsignificant (< 50% stenosis) or a vessel > 12 mm in diameter by visual estimation;
  • the patient is now participating in another clinical trial to evaluate drug or medical device;
  • patient enrolled for this trial before;
  • prenatal pregnancy test result for women of childbearing potential is non-negative, Lactating woman;
  • patients, who underwent major surgical procedures (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study;
  • patients scheduled to undergo major surgery (eg, thoracotomy, craniotomy, etc.) within 30 days after enrolment;
  • central veins lesions have been already treated with DCB before
  • presence of a bare metal stent (BMS) or stent graft or vascular access thrombosis in central veins
  • patients allergic or intolerant to paclitaxel, or contrast media;
  • patients whose life expectancy is less than 1 year
  • presence of Thrombus in central veins
  • tumor compression
  • thoracic inlet syndrome
  • patients implanted with pacing or cardioverter devices with leads
  • any other central line within the target lesion
  • Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514406


Contacts
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Contact: Petra Michel, MD +4902932/952-343926 P.Michel@klinikum-hochsauerland.de

Locations
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Germany
Vivantes Klinikum
Berlin, Germany, 10249
Contact: Michael Burbelko, MD       Michael.Burbelko@vivantes.de   
St.Franziskus Hospital
Münster, Germany, 48145
Contact: Michel Bosiers, MD         
Switzerland
Hopitaux Universitaires Geneve
Geneva, Geneve, Switzerland, 1205
Contact: Frederic Glauser, MD       frederic.glauser@hcuge.ch   
Hopital de la Providence
Neuchâtel, Neuchatel, Switzerland, 2000
Contact: Amine Chouiter, MD       amine.chouiter@h-ne.ch   
Sponsors and Collaborators
Cardionovum GmbH
CliPS Service
OPIS srl
Investigators
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Principal Investigator: Petra Michel, MD Klinikum Hochsauerland
Study Director: Michael Lichtenberg, MD, FESC Klinikum Hochsauerland
More Information
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Responsible Party: Cardionovum GmbH
ClinicalTrials.gov Identifier: NCT04514406    
Other Study ID Numbers: APERTO CVS
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardionovum GmbH:
Drug Coated Balloon
Central Veins Stenosis
Percutaneous Intervention
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical