REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®

• ClinicalTrials.gov Identifier: NCT04479020
• Recruitment Status: Active, not recruiting
• First Posted: July 21, 2020
• Last Update Posted: July 21, 2020
• Sponsor: Acandis GmbH
• Information provided by (Responsible Party): Acandis GmbH

Study Description

Brief Summary:

The purpose of the Aperio® PMCFU is to collect data in clinical practice of the Aperio® and Aperio® Hybrid Device, which is intended to restore blood flow in the neurovasculature by removing thrombus in patients, experiencing ischemic stroke. Recanalisation status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.

Condition or disease	Intervention/treatment
Acute Stroke	Device: Mechanical Thrombectomy

Detailed Description:

Study Type: prospective, multicenter, single-arm, open-label Participants: 10 participating centers in Germany planned PI: Dr. Franziska Dorn, University Hospital Munich, Germany Estimated Enrolment: A minimum of 130 patients treated with the Aperio® or Aperio® Thrombectomy Device due to thrombotic occlusion of the anterior or posterior circulation arteries with a diameter <3mm

Follow up: 3 months Estimated Final Assessment: End of 2022

This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up Study to collect comprehensive information on technical and clinical success and safety of the use of Aperio® and Aperio® Hybrid Thrombectomy Device in arteries <3mm in clinical practice. Aperio® and Aperio® Hybrid Thrombectomy Device will be used within its approved indication.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Months
• Official Title: REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: January 2022

Groups and Cohorts

Intervention Details:

• Device: Mechanical Thrombectomy
  Mechanical thrombectomy requiring the use an Aperio® or Aperio® Hybrid Thrombectomy device due to an thrombotic occlusion in the anterior and posterior circulation arteries with a diameter <3mm

Outcome Measures

Primary Outcome Measures :

1. Safety and Efficacy [ Time Frame: Immediatley after interventional procedure ]

   Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the Aperio® and Aperio® Hybrid Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device.

   mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion

2. Neurological Outcome [ Time Frame: Immediately after interventional procedure ]

   Neurological outcome assessed by mRS (modified Ranking Scale)= 0-2 0 No Symptoms

   1. No significant disability, despite symptoms, able to perform all usual duties and activities
   2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
   3. Moderate disability; requires some help, but able to walk without assistance
   4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
   5. Severe disability bedridden incontinent and requires constant nursing care and attention
   6. Patient died

Secondary Outcome Measures :

1. Good neurological outcome [ Time Frame: at 90 days(+-10 days) ]

   mRS (modified Ranking Scale)= 0-2

   0 No Symptoms

   1. No significant disability, despite symptoms, able to perform all usual duties and activities
   2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
   3. Moderate disability; requires some help, but able to walk without assistance
   4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
   5. Severe disability bedridden incontinent and requires constant nursing care and attention
   6. Patient died

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an Aperio® or Aperio® Hybrid Thrombectomy Device due to a thrombotic occlusion in the anterior and posterior circulation arteries with a vessel diameter <3mm.

Criteria

Inclusion Criteria:

• Any patient treated according to IFU with the Aperio® or Aperio® Hybrid Thrombectomy Device due to occlusion in arteries <3mm of the anterior or posterior circulation
• Age ≥ 18 years

Exclusion Criteria:

• pre stroke mRS ≥ 3
• Any contraindication according to IFU

Contacts and Locations

Locations

Germany

Klinikum der Ludwig-Maximilian-Universität München

München, Germany, 81377

Sponsors and Collaborators

Acandis GmbH

More Information

• Responsible Party: Acandis GmbH
• ClinicalTrials.gov Identifier: NCT04479020
• Other Study ID Numbers: REVISAR
• First Posted: July 21, 2020
• Last Update Posted: July 21, 2020
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases