APERTO CVS PMCF Study

Stenosis Clinical Trial

— APERTO CVS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04514406
• Other study ID #: APERTO CVS
• Status: Terminated
• Start date: January 25, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Cardionovum GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Vein Obstruction
• Constriction, Pathologic
• Dialysis; Complications
• Restenosis
• Stenosis

Intervention

Device:
• APERTO OTW DCB
Drug Coated Balloon Angioplasty

Locations

Country	Name	City	State
Germany	Vivantes Klinikum	Berlin
Germany	St.Franziskus Hospital	Münster

Sponsors (3)

Lead Sponsor	Collaborator
Cardionovum GmbH	CliPS Service, OPIS srl

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural Technical Success	Residual stenosis is no more than 30% after treatment with APERTO OTW measured by angiography	intraoperative
Secondary	Procedural Clinical Success	After the procedure, haemodialysis access function improved, dialysis function restored, and at least one dialysis session completed	intraoperative
Secondary	Procedural Surgical Success	On the basis of technical success, no major adverse events (MAE) occurred during hospitalization or treatment	intraoperative
Secondary	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
Secondary	Fistula Flow	Flow measured with Echo Doppler measured at 6 months	6 months
Secondary	Recirculation Rate	Recirculation rate measured at 6 months	6 months