APERTO CVS PMCF Study

NCT ID: NCT04514406

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-12-01

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

Conditions

Dialysis; Complications; Central Vein Obstruction; Stenosis; Restenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

APERTO OTW DCB

Dialysis patients treated with APERTO OTW following (re)stenosis of central veins

APERTO OTW DCB

Intervention Type: DEVICE

Drug Coated Balloon Angioplasty

Interventions

APERTO OTW DCB

Drug Coated Balloon Angioplasty

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CliPS Service

UNKNOWN

Sponsor Role: collaborator

OPIS srl

UNKNOWN

Sponsor Role: collaborator

Cardionovum GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra Michel, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Hochsauerland

Michael Lichtenberg, MD, FESC

Role: STUDY_DIRECTOR

Klinikum Hochsauerland

Locations

Vivantes Klinikum

Berlin, , Germany

St.Franziskus Hospital

Münster, , Germany

Countries

Germany

Other Identifiers

APERTO CVS

Identifier Type: -

Identifier Source: org_study_id