NCT04514406

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

August 5, 2020

Last Update Submit

February 6, 2024

Conditions

Dialysis; ComplicationsCentral Vein ObstructionStenosisRestenosis

Keywords

Drug Coated BalloonCentral Veins StenosisPercutaneous Intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Procedural Technical Success

    intraoperative

  • Procedural Clinical Success

    intraoperative

  • Procedural Surgical Success

    intraoperative

  • Major Adverse Event

    12 months follow up

  • Fistula Flow

    6 months

  • +1 more secondary outcomes

Study Arms (1)

APERTO OTW DCB

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

Device: APERTO OTW DCB

Interventions

APERTO OTW DCBDEVICE

Drug Coated Balloon Angioplasty

APERTO OTW DCB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dialysis patients with symptoms for stenosis or restenosis of central veins to be treated with percutaneous angioplasty.

You may qualify if:

  • 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;

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vivantes Klinikum

Berlin, 10249, Germany

Location

St.Franziskus Hospital

Münster, 48145, Germany

Location

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Petra Michel, MD

    Klinikum Hochsauerland

    PRINCIPAL INVESTIGATOR

  • Michael Lichtenberg, MD, FESC

    Klinikum Hochsauerland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 17, 2020

Study Start

January 25, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)