APERTO CVS PMCF Study (APERTO CVS)

APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients

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

Study Overview

• Status: Terminated
• Conditions: Restenosis; Stenosis; Dialysis; Complications; Central Vein Obstruction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

• Study Contact: Name: Petra Michel, MD; Phone Number: +4902932/952-343926; Email: P.Michel@klinikum-hochsauerland.de

Study Locations

• Germany
  • Berlin, Germany, 10249
    • Vivantes Klinikum
    • Contact: Michael Burbelko, MD; Email: Michael.Burbelko@vivantes.de
  • Münster, Germany, 48145
    • St.Franziskus Hospital
    • Contact: Michel Bosiers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Assessed Intervention free period at 6 months fup	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Technical Success	Residual stenosis is no more than 30% after treatment with APERTO OTW measured by angiography	intraoperative
Procedural Clinical Success	After the procedure, haemodialysis access function improved, dialysis function restored, and at least one dialysis session completed	intraoperative
Procedural Surgical Success	On the basis of technical success, no major adverse events (MAE) occurred during hospitalization or treatment	intraoperative
Major Adverse Event	include death, stroke, thrombosis, allergic reactions, and pulmonary diseases (including pulmonary edema), bleeding complication with the need of transfusion	12 months follow up
Fistula Flow	Flow measured with Echo Doppler measured at 6 months	6 months
Recirculation Rate	Recirculation rate measured at 6 months	6 months

Collaborators and Investigators

• Sponsor: Cardionovum GmbH
• Collaborators: CliPS Service; OPIS srl
• Investigators: Principal Investigator: Petra Michel, MD, Klinikum Hochsauerland; Study Director: Michael Lichtenberg, MD, FESC, Klinikum Hochsauerland

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Drug Coated Balloon; Central Veins Stenosis; Percutaneous Intervention
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: APERTO CVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No