Delphi Early Feasibility Study

Ischemic Stroke Clinical Trial

— DELPHI EFS  

Official title:

Delphi Early Feasibility Study (DELPHI EFS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022069
• Other study ID #: D001-PRT21-026
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: University at Buffalo
• Contact: Jennifer Gay, CCRP
• Phone: 7164404231
• Email: jgay[@]ubns.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An early feasibility study to evaluate the safety and first pass effect technical assessment of Delphi Revascularization Device for clot retrieval in Anterior circulation ischemic stroke in the intracranial ICA, MCA M1 and proximal dominant MCA M2, up to 8hrs of symptom onset or Last Known Well (LKW).

Description:

The Delphi Revascularization Device is a stent retriever that has electrical current applied and is a combination of the Solitaire™ X Revascularization Device and an accessory device to apply the electrical current, the ADD. There is bench evidence that electrical current changes the properties of the clot, which can improve clot adhesion and neurothrombectomy, and an improved rate of first pass success. The small electric current is intended to polymerize the proteins in the clot and cause better clot engagement and this in turn would have better first pass effect, lower chances of safety issues and better long-term clinical outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age at time of consent
• The patient or patient's LAR has signed and dated an ICD using the Institutional Review Board (IRB) and Medtronic Approved ICD and agrees to comply with protocol requirements. Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization has been provided and signed by the patient or patient's LAR;
• Has baseline National Institutes of Health Stroke Scale (NIHSS) = 8;
• Able to be treated within 8 hours of stroke symptom onset or
• Last Known Normal (LKN);
• Confirmed LVO in the anterior circulation (i.e., intracranial ICA, M1 or proximal dominant M2) as confirmed by CTA or MRA;
• Has a Pre-stroke Modified Rankin Score (mRS) = 1;
• Has an Alberta Stroke Program Early CT Score (ASPECTS) 6 - 10;
• Use of Solitaire device as primary approach to thrombectomy, with or without conjunct aspiration; If tPA is indicated, initiation of IV tPA should be administered as soon as possible to not delay usual care* and no later than 3.0 hours from onset of stroke symptoms or LKW, with investigator verification that the patient has received/is receiving the correct IV tPA dose (0.9mg/kg) for the estimated weight; and
• Is ineligible for IV-tPA or failed to achieve recanalization (mTICI 2b or higher) of target large vessel occlusion after administration of IV-tPA.

Exclusion Criteria:

• Cannot provide consent or legally authorized representative not available to provide consent;
• Has evidence of intracranial hemorrhage on CT or MRI;
• Has known history of epilepsy;
• Has recurrent stroke within last three months;
• Has known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
• Has baseline platelet count < 30.000 / µL;
• Has baseline blood glucose of < 50mg/dL;
• Has severe, sustained hypertension (SBP > 185mm Hg or DBP > 110 mm Hg);
• Is Covid-19 positive or have active Covid-19 infection;
• Female patient, of child-bearing potential, who is pregnant(confirmed with a positive pregnancy test) or breastfeeding at the time of admission or plans to become pregnant during their participation in the study;
• Patient 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; and/or
• Has a severe health condition that may potentially result in death within 6 months.
• Patients with known nickel sensitivity.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• thrombectomy
Delphi Revascularization device is an investigational device. The device is itself a combination of SolitaireX™ Revascularization device and Artisse Detachment Device to apply 2mAmp constant current to the Solitaire device via ADD

Locations

Country	Name	City	State
United States	kaledia Health/Buffalo General Medical Center/GVI	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate technical efficacy outcomes with radiographical measurements	• Overall post-procedure first pass revascularization success as defined by mTICI=2B using DSA;	Day 1
Primary	outcomes with radiographical measurements	• Final mTICI post procedure using DSA	day 1
Primary	Evaluate technical efficacy outcomes with radiographical measurements	• Target vessel re-occlusion within 3 days per CTA or MRA	3 days
Primary	Evaluate technical efficacy outcomes with radiographical measurements	Comparison of predictive (via CTP) and final infarct (via MRI FLAIR) volumes at Day 3; and; Final infarct volume via MRI FLAIR at 90 days.	90 days