APERTO CVS PMCF Study

Cardionovum

Status

Terminated

Conditions

Central Vein Obstruction

Restenosis

Dialysis; Complications

Stenosis

Treatments

Device: APERTO OTW DCB

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT04514406

APERTO CVS

Details and patient eligibility

About

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

Full 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

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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