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Pipeline™ Flex Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE) (ADVANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873714
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Shield™ device in the treatment of unruptured or ruptured, wide-necked intracranial aneurysms.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Pipeline™ Flex Embolization Device with Shield Technology™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Pipeline™ Flex Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms
Estimated Study Start Date : January 25, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pipeline™ Shield™ Embolization Device
Pipeline™ Flex Embolization Device with Shield Technology™
Device: Pipeline™ Flex Embolization Device with Shield Technology™
Pipeline™ Embolization Device / Pipeline™ Flex Embolization Device with Shield Technology™
Other Name: Pipeline™ Shield™




Primary Outcome Measures :
  1. Safety: Incidence of major stroke [ Time Frame: 1 year post-procedure ]
    Incidence of major stroke in the territory supplied by the treated artery or neurological death.


Secondary Outcome Measures :
  1. Effectiveness: Incidence of successful device implantation [ Time Frame: Day 0 ]
    Incidence of successful device implantation at the target site

  2. Effectiveness: Incidence of complete aneurysm occlusion [ Time Frame: 1 and 3 years post-procedure ]
    Incidence of complete aneurysm occlusion (Raymond Roy Class 1)

  3. Effectiveness: Raymond Roy Scale Class 1 [ Time Frame: 1 and 3 years post-procedure ]
    Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without retreatment, or significant parent artery stenosis (≥ 50% as measured by DSA) or flow limiting stenosis (≥ 50% as measured by MRA)

  4. Effectiveness: Incidence of target aneurysm recanalization [ Time Frame: 1 and 3 years post-procedure ]
    Incidence of target aneurysm recanalization

  5. Safety: Incidence of major stroke [ Time Frame: 2 and 3 years post-procedure ]
    Incidence of major stroke in the territory supplied by the treated artery or neurological death

  6. Safety: Incidence of major stroke [ Time Frame: 30 days post-procedure ]
    Incidence of major stroke in the territory supplied by the treated artery or neurological death

  7. Safety: Incidence of delayed intraparenchymal hemorrhage [ Time Frame: >30 days post-procedure through 1 year post-procedure ]
    Incidence of delayed intraparenchymal hemorrhage

  8. Safety: Incidence of subjects with disabling strokes [ Time Frame: 1 year, 2 year, and 3 year post-procedure ]
    Incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Imaging):

  • Subject has a target intracranial aneurysm located in the internal carotid artery (up to the terminus).
  • Subject has a target intracranial aneurysm with an aneurysm neck ≥4mm or a dome-to-neck ratio of < 2.
  • Subject has a target intracranial aneurysm that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target intracranial aneurysm.

Inclusion Criteria (Clinical):

  • Subject (or subject's legally authorized representative) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with protocol requirements. HIPAA/data protection authorization has been provided and signed by the subject (or subject's legally authorized representative).
  • Age 22-80 years at the time of consent.
  • Life expectancy ≥3 years
  • Subject has a mRS ≤ 2 at baseline to be determined by a certified independent assessor at the site.
  • Subject has already been selected for endovascular treatment of the target aneurysm.
  • Subject's last recorded P2Y12 reaction units (PRU) value is between ≥60 and ≤200 prior to study procedure. For OUS sites, a Thromboelastogram (TEG) test may be carried out instead of the PRU test (depending on PRU test availability). In cases where TEG test is carried out, the subject should have a pre-procedure therapeutic ADP% between >30% to <90%.
  • Subject has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment to outweigh the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.

Exclusion Criteria (Imaging):

  • Subject has internal carotid artery bifurcation aneurysm.
  • Aneurysms that arise from the Posterior Communicating Artery (PComm).
  • The internal carotid artery aneurysms of the C7 segment will be excluded under the following conditions:

    1. Observed posterior communicating artery (PComm) of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA)
    2. PComm overlapping with the aneurysm neck
    3. PComm branch arising from the dome of the aneurysm
  • Subject has aneurysm arising from internal carotid artery but is primarily fed by posterior circulation (i.e., retrograde flow from the basilar artery) as confirmed by DSA

Exclusion Criteria (Clinical):

  • Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm during the study period.
  • Subject has received an intracranial implant (e.g. coils) in the area of the target intracranial aneurysm within the past 6 months prior to the study procedure.
  • Subject has had a SAH and/or target aneurysm rupture in the past 30 days prior to the study procedure.
  • Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
  • Vessel characteristics (e.g. severe tortuosity, stenosis, morphology) that preclude safe endovascular access to the aneurysm to allow for necessary access to treat with the study device.
  • Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g. arteriovascular malformation).
  • History of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
  • Subject requires adjunctive device use (e.g. coils) during the index procedure.
  • Subject has extradural target aneurysm <12mm which is not symptomatic or not exhibiting aneurysm growth (exception: unless it is a fusiform aneurysm <12 mm i.e., asymptomatic extradural fusiform aneurysms <12 mm can be included).
  • Any known contraindication to treatment with the Pipeline™ Flex Embolization Device with Shield Technology™, or use of antiplatelet therapy including:

    1. Active bacterial infection
    2. Pre-existing stent is in place in the parent artery at the target intracranial aneurysm location
    3. Contraindication to DAPT agents
  • Platelet count < 100 x 10^3 cells/mm^3 or known platelet dysfunction.
  • The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
  • Subject is pregnant or wishes to become pregnant during the first year of study participation.
  • Subject is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation.
  • Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
  • History of previous acute ischemic stroke

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT03873714    
Other Study ID Numbers: COVSHLD0569
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases