International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach (IMPACT)

Stryker

Status

Active, not recruiting

Conditions

Intracranial Aneurysm

Treatments

Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent

Study type

Observational

Funder types

Industry

Identifiers

NCT04572230

CDM10001731

Details and patient eligibility

About

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

Full description

IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used.

In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.

Enrollment

405 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Evolve EU and Evolve FR):

Subject has an intracranial aneurysm that can be treated with one of the proposed devices
Subject age is ≥ 18 years
Subject or subject's legally authorized representative (LAR) has signed written informed consent
Subject is willing to comply with scheduled visits and examinations per institutional standard of care

Exclusion Criteria for (Evolve EU and Evolve FR):

Subject is pregnant or plans to become pregnant her study participation*.
Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device study.
Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow-up, e.g.).
Subject has a non-target aneurysm treated within 30 days prior to study enrollment.
Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study.
Subject target aneurysm is a ruptured intracranial aneurysm (unless ruptured at least 21 days prior the day of the index procedure)
Subject has a target aneurysm other than saccular or fusiform intracranial aneurysms; e.g.: vertebrobasilar dolichoectasia (VBD)
The parent vessel size does not fall within the indicated range defined by IFU
Antiplatelet and/or anticoagulation therapy (e.g., aspirin and clopidogrel) is contraindicated for the subject
Subject has not received dual anti-platelet agents prior to the procedure or equivalent in accordance with standard medical practice
Subject has an active bacterial or viral infection
The angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
Severe intracranial vessel tortuosity or stenosis; and/or
Intracranial vasospasm not responsive to medical therapy

Additional Key Exclusion Criteria (Evolve EU only):

Subject has a non-target aneurysm treated within 30 days prior to study enrollment
Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study
Subject has a modified Rankin Score (mRS) ≥3 at pre-procedure examination
Subject has undergone previous stent assisted coiling or flow diverter treatment of a parent artery aneurysm near the location of the target aneurysm