Dialysis; ComplicationsAPERTO CVSNCT04514406

APERTO CVS PMCF Study

An observational study of Dialysis; Complications and Central Vein Obstruction, run by Cardionovum GmbH at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dialysis; Complications, Central Vein Obstruction, Stenosis
What is being tested?: APERTO OTW DCB
Type of treatment: Medical device
How many people: 6 participants
Where: 2 sitesGermany
Study dates: 25 Jan 2021to 1 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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;

Who cannot join

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;

Show all 16Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Vivantes Klinikum
Berlin, 10249
St.Franziskus Hospital
Münster, 48145

Other trials in Germany

About this study

Official title: 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

Read the 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
Being tested: APERTO OTW DCB
Keywords: Drug Coated Balloon, Central Veins Stenosis, Percutaneous Intervention
Medical subject headings: Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

APERTO OTW DCBDevice
Drug Coated Balloon Angioplasty

Study groups in NCT04514406
Study group	Role	What they receive
APERTO OTW DCB		Dialysis patients treated with APERTO OTW following (re)stenosis of central veins Receives: Device: APERTO OTW DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20211 Dec 2023

First posted17 Aug 2020
Study start25 Jan 2021
Primary completion1 Dec 2023
Study completion1 Dec 2023

Why it stopped: no enrolments

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04514406
Sponsor's protocol ID: APERTO CVS
Acronym: APERTO CVS
Status last verified: Feb 2024
First submitted: 5 Aug 2020
Last updated: 7 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication

All Dialysis; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients
ClinicalTrials.gov ID: NCT04514406
Acronym / sponsor ID: APERTO CVS / APERTO CVS
Conditions: Dialysis; Complications, Central Vein Obstruction, Stenosis, Restenosis
Keywords: Drug Coated Balloon, Central Veins Stenosis, Percutaneous Intervention
Study type: Observational
Recruitment status: TerminatedReason stopped: no enrolments
Enrolment: 6 participants (actual)
Lead sponsor: Cardionovum GmbHIndustry (pharma, biotech, devices)
Collaborators: CliPS Service, OPIS srl
Study start: 25 Jan 2021 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 17 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
APERTO OTW DCB	–	Device: APERTO OTW DCBDialysis patients treated with APERTO OTW following (re)stenosis of central veins

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Dialysis patients with symptoms for stenosis or restenosis of central veins to be treated with percutaneous angioplasty.

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
APERTO OTW DCBDrug Coated Balloon Angioplasty	Device	APERTO OTW DCB

Primary outcome

Clinically Assessed Intervention free period at 6 months fup
Time frame: 6 months
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 secondary outcomes

Procedural Technical Success
Time frame: intraoperative
Procedural Clinical Success
Time frame: intraoperative
Procedural Surgical Success
Time frame: intraoperative
Major Adverse Event
Time frame: 12 months follow up
Fistula Flow
Time frame: 6 months
Recirculation Rate
Time frame: 6 months

Results and safety

The study was stopped early (reason given: no enrolments). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Dialysis; Complications

RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Petra Michel, MD principal investigator

Klinikum Hochsauerland

Michael Lichtenberg, MD, FESC study director

Klinikum Hochsauerland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dialysis; Complications and Central Vein Obstruction, run by Cardionovum GmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: no enrolments). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Assessed Intervention free period at 6 months fup (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.