APERTO CVS PMCF Study

Terminated

• Conditions: Dialysis; Complications; Stenosis; Central Vein Obstruction; Restenosis

• Registration Number: NCT04514406
• Lead Sponsor: Cardionovum GmbH

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

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Study Start: 2021-01-25
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically Assessed Intervention free period at 6 months fup	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Vivantes Klinikum; 🇩🇪 Berlin, Germany

St.Franziskus Hospital; 🇩🇪 Münster, Germany