Clinical trial NCT04514406: APERTO CVS PMCF Study
Official title: APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dialysis; Complications
Central Vein Obstruction
Stenosis
Restenosis
Keywords: Drug Coated Balloon
Central Veins Stenosis
Percutaneous Intervention
Lead sponsor: Cardionovum GmbH
Sponsor class: INDUSTRY
Collaborators: name: CliPS Service
name: OPIS srl
First posted: 2020-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dialysis patients with symptoms for stenosis or restenosis of central veins to be treated with percutaneous angioplasty.

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

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

Eligibility 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

Primary outcomes:
measure: Clinically Assessed Intervention free period at 6 months fup
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Technical Success
timeFrame: intraoperative
measure: Procedural Clinical Success
timeFrame: intraoperative
measure: Procedural Surgical Success
timeFrame: intraoperative
measure: Major Adverse Event
timeFrame: 12 months follow up
measure: Fistula Flow
timeFrame: 6 months
measure: Recirculation Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum
city: Münster
country: Germany
facility: St.Franziskus Hospital
Study officials:
affiliation: Klinikum Hochsauerland
name: Petra Michel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Hochsauerland
name: Michael Lichtenberg, MD, FESC
role: STUDY_DIRECTOR
References: