Clinical Trial Portfolio

Sequent Medical, Inc. & MicroVention

Master Clinical Trial & Registry Log

Historical Era: Pre-Acquisition / Transitional Era (2010–2016)

Note: These clinical trial programs were managed and executed by Andrew Schachter and his team, leveraging decades of neurovascular and medical device trial expertise.

Sequent Medical, Inc.

WEB™ Aneurysm Embolization System

Product Portfolio: Woven EndoBridge (WEB™) Aneurysm Embolization System

THE EUROPEAN CORE PROTOCOLS (CE MARK FOUNDATIONS)

These prospective, multicenter Good Clinical Practice (GCP) studies built the initial safety profile for the device in Europe, tracking the architectural shift from the thick dual-layer device (WEB-DL) to the streamlined single-layer device (WEB-SL).

WEBCAST (WEB Clinical Assessment of IntraSaccular Aneurysm Therapy)

NCT01778322

Study Design: Prospective, multicenter, non-randomized interventional study.

Geographic Scope: 3 European countries (France, Germany, Hungary) across 6 primary neurovascular centers.

Primary Objective: To establish the foundational 6-month and 1-year safety, technical success, and anatomical occlusion metrics of the original WEB-DL device.

WEBCAST-2

NCT01778322 (Tracked under the expanded WEBCAST framework)

Study Design: Prospective, multicenter, non-randomized single-arm registry.

Geographic Scope: Expanded European centers (10 active sites; 55 enrolled patients).

Primary Objective: To evaluate the next-generation iteration—the single-layer WEB-SL. This trial proved that reducing nitinol braid density down to a single-layer configuration preserved the low-porosity blood-stasis effect while improving device delivery.

The French Observatory

NCT01975233

Study Design: Large-scale prospective, consecutive, multicenter real-world registry.

Geographic Scope: 11 major neurointerventional departments strictly located across France.

Primary Objective: Real-world pragmatism. It observed consecutive, unselected patient enrollments to test device navigation, placement success, and repeatability outside of rigid trial exclusion criteria.

Data from WEBCAST, WEBCAST-2, and the French Observatory were later pooled into landmark 'Cumulative Population' long-term publications.

THE EMERGENCY & HIGH-RISK MANDATE

CLARYS (Clinical Assessment of WEB Device in Ruptured Aneurysms)

Study Design: Prospective, multicenter, single-arm observational registry.

Geographic Scope: 15 high-volume neurointerventional sites across France and Germany.

Primary Objective: Specifically isolated subarachnoid hemorrhage (SAH) patients. It monitored whether the quick-deployment intrasaccular mechanism could safely seal an actively or recently ruptured aneurysm during acute emergency windows without causing severe rebleeding or requiring aggressive dual-antiplatelet therapy (DAPT).

U.S. IDE TRIAL

WEB-IT (The WEB Intrasaccular Therapy Study)

NCT02191618

Study Design: Prospective, multicenter, single-arm, pivotal Investigational Device Exemption (IDE) trial.

Geographic Scope: Global pipeline featuring 150 patients across 31 world-class sites spanning the United States, Canada, and Europe.

Primary Objective: Sequent Medical's core regulatory push to secure FDA Premarket Approval (PMA). It explicitly targeted wide-neck bifurcation aneurysms (WNBAs) located at major vascular junctions (MCA, basilar apex, ACom, and ICA).

Historical Milestone: The successful database lock of this registry and the submission of its early clinical success profile was the primary commercial asset that drove Terumo Corporation to execute its $280 million corporate buyout of Sequent Medical in mid-2016.

End of Sequent Medical Document

MicroVention

Neurovascular Device Trial Portfolio

A high-level log of pivotal clinical trials across MicroVention's neurovascular device portfolio.

1. THE FRED® STENT PORTFOLIO (FLOW DIVERSION)

These trials evaluated MicroVention's self-expanding braided nitinol mesh designed to redirect blood flow away from the aneurysm dome, charting the evolution from the original device to the antithrombotic surface-treated version.

Pivotal US FRED Trial (2013–2018)

NCT01801007

Study Design: Prospective, multicenter, single-arm, pivotal study.

Geographic Scope: 154 patients across major US neurovascular centers.

Primary Objective: To evaluate safety and effectiveness to secure the foundational US FDA Premarket Approval (PMA), which was officially granted in 2019.

2. THE LVIS® & LVIS® Jr. PORTFOLIO (STENT-ASSISTED COILING)

These trials verified the highly conformable, braided single-wire neurovascular stents used to bridge the neck of wide-necked aneurysms during coiling procedures.

Pivotal US LVIS Trial (2014–2018)

Study Design: Prospective, multicenter, single-arm landmark clinical trial.

Geographic Scope: Top-tier neurointerventional sites across the United States.

Primary Objective: To transition the LVIS system from its early Humanitarian Device Exemption (HDE) pathway into full US FDA PMA approval, which was achieved in May 2018.

3. THE SOFIA® PORTFOLIO (ACUTE ISCHEMIC STROKE THROMBECTOMY)

These trials focused on MicroVention's entry into mechanical thrombectomy using high-trackability, direct-aspiration catheters for large vessel occlusions (LVO).

The SOFAST Study (Concluded & Published July 2024)

Study Design: Prospective, multicenter, single-arm, post-market trial.

Geographic Scope: 108 patients across major designated stroke centers in the United States.

Primary Objective: To assess the workflow efficiency and safety of the 6 French SOFIA™ Flow Plus Aspiration Catheter used as a first-line direct aspiration technique for rapid endovascular clot retrieval.

4. MICROVENTION-ERA WEB® & SYSTEM-WIDE REGISTRIES

Following the 2016 acquisition of Sequent Medical, MicroVention pushed forward with post-approval monitoring and scaling the device down into smaller microcatheter platforms.

WEB-IT PAS (Post-Approval Study)

Study Design: Mandated prospective, post-market surveillance registry.

Geographic Scope: Expanded commercial hospital networks across the United States.

Primary Objective: To continuously monitor and report real-world commercial safety and deployment metrics following the WEB system's official 2019 FDA approval.

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