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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04704258
Other study ID # #2020-01 (EU)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date June 6, 2023

Study information

Verified date February 2024
Source AorticLab Srl
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic Valve Implant).


Description:

A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 6, 2023
Est. primary completion date June 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects of age = 18 years 2. Subject is scheduled to undergo transfemoral aortic valve implant (TAVI) procedure on a stenotic native aortic valve and is qualified based on pre-operative CT-scan examination (trans-thoracic echocardiogram (TTE) can be used as confirmatory assessment) 3. Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size 4. The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits 5. The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB) Exclusion Criteria: Clinical exclusion criteria (preoperative screening) 1. Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin 2. Subjects with contraindication to cerebral MRI 3. Subjects with a history of a stroke or transient ischemic attack within the prior 6 months 4. Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure 5. Renal insufficiency (creatinine > 3.0 mg/dL or Glomerular Filtration Rate GFR < 30) and/or renal replacement therapy at the time of screening 6. Subjects with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months 7. Subjects with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated 8. Subject is currently participating in another drug or device clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation 9. Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI) 10. Subject requires an emergent procedure 11. Subject has active major psychiatric disease 12. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities 13. Subject has an ejection fraction of 30% or less 14. Subjects with active endocarditis or other systemic infection 15. Subjects undergoing therapeutic thrombolysis 16. Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test Computerized Tomographic exclusion criteria (preoperative screening) 1. Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch 2. Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation 3. Subjects with a diameter of the ascending aorta < 25 and > 39 mm at baseline CT (measured 10 mm upstream of the first vessel of the brachiocephalic trunk) 4. Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route 5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access 6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TAVI (Transcatheter Aortic Valve Implant)
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
Device:
FLOWer Embolic Protection System
FLOWer Embolic Protection System

Locations

Country Name City State
Belgium HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim Antwerp
Belgium CUB Hôpital Erasme (ULB) Brussels
Italy IRCCS Ospedale San Raffaele Milan MI
Italy Centro Cardiologico Monzino IRCCS Milano
Italy Casa di Cura Policlinico di Monza Monza MB
Italy Clinica San Gaudenzio Novara
Italy San Carlo Azienda Ospedaliera Regionale Potenza PZ
Italy IRCCS Policlinico San Donato San Donato Milanese MI

Sponsors (2)

Lead Sponsor Collaborator
AorticLab Srl Meditrial Europe Ltd.

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events Primary Safety Endpoint: FLOWer device Safety, rate of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. MACCEs are based on the Valve Academic Research Consortium (VARC- 3) criteria:
all death;
all stroke (disabling and non-disabling);
acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first)
30 days
Primary Reduction in total volume of new cerebral lesions in all territories at serial DWMRI Primary Clinical Benefit Endpoint: Reduction in total volume of new cerebral lesions in all territories at serial DWMRI, compared to historical data in control arm (unprotected) data from previous randomized studies Within 2-5 days after procedure vs. baseline
Secondary Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. Secondary Safety Endpoint: Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. all-cause mortality including cardiovascular mortality;
all stroke (disabling and non-disabling);
bleeding (life-threatening or disabling);
acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first);
major device access related vascular complications;
coronary artery obstruction requiring intervention;
valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, repeat TAVI, or surgical aortic valve replacement).
7 and 30 days
Secondary Brain imaging (DW-MRI) Secondary Clinical Benefit Endpoints: Acute cerebral embolic burden reduction after TAVI, defined as number and volume of new cerebral lesions in all cerebral territories assessed by DW-MRI Within 2-5 days after procedure vs. baseline
Secondary Neurocognitive Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS 2-7 days and 30-days vs. baseline
Secondary Technical Success Secondary Performance Endpoints: Technical Success defined as successful placement, insertion and removal of the FLOWer System Immediately after procedure
Secondary Debris capture Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition Immediately after procedure
Secondary FLOWer System Usability Secondary Performance Endpoints: FLOWer System Usability graded by the Investigator with a 5-point Likert scale
The minimum and the maximum values of the scale are defined as follows:
(1) Unacceptable; (2) Poor; (3) Acceptable; (4) Good; (5) Excellent
Immediately after procedure
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