---
title: Basilar Artery International Cooperation Study
nct_id: NCT01717755
overall_status: UNKNOWN
phase: NA
sponsor: Erik van der Hoeven
study_type: INTERVENTIONAL
primary_condition: Basilar Artery Thrombosis
countries: Brazil, Germany, Italy, Netherlands, Norway, Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01717755.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01717755"
ct_last_update_post_date: 2018-01-18
last_seen_at: "2026-05-12T06:45:14.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Basilar Artery International Cooperation Study

**NCT ID:** [NCT01717755](https://clinicaltrials.gov/study/NCT01717755)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 282
- **Lead Sponsor:** Erik van der Hoeven
- **Collaborators:** BASICS Study Group
- **Conditions:** Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery, Stroke, Cerebrovascular Disorders, Basilar Artery Occlusion
- **Start Date:** 2011-10
- **Completion Date:** 2020-01
- **CT.gov Last Update:** 2018-01-18

## Brief Summary

Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.

Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.

Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.

Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.

Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.

Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion criteria

* Symptoms and signs compatible with ischemia in the basilar artery territory.
* Basilar artery occlusion (BAO) confirmed by CTA or MRA.
* Age 18 years or older (i.e., candidates must have had their 18th birthday).
* If IVT is considered as part of best medical management, IVT should be started within 4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset of acute symptoms leading to clinical diagnosis of BAO or if not known last time patient was seen normal prior to onset of these symptoms).
* Initiation of IAT should be feasible within 6 hours of estimated time of BAO.

Exclusion criteria

* Pre-existing dependency with mRankin ≥3.
* Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
* Patients who require hemodialysis or peritoneal dialysis.
* Other serious, advanced, or terminal illness.
* Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
* Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
* Informed consent is not or cannot be obtained.

Imaging exclusion criteria

* High-density lesion consistent with hemorrhage of any degree.
* Significant cerebellar mass effect or acute hydrocephalus.
* Bilateral extended brainstem ischemia.
```

## Arms

- **Best medical management.** (NO_INTERVENTION) — Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis.

If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
- **Additional intra-arterial treatment.** (EXPERIMENTAL) — Best medical management followed by intra-arterial treatment and best medical management

## Interventions

- **Intra-arterial treatment** (OTHER) — IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.

## Primary Outcomes

- **Favourable outcome** _(time frame: day 90)_ — Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

## Secondary Outcomes

- **Excellent outcome** _(time frame: day 90)_
- **Modified Rankin Score** _(time frame: day 90)_
- **NIHSS** _(time frame: pre IVT, pre randomization, 24h post treatment)_
- **EQ-5D** _(time frame: day 90 and 12 months)_

## Locations (27)

- Fortaleza General Hospital, Fortaleza, Brazil — _RECRUITING_
- Hospital das Clinicas de Ribeirao Preto, Ribeirão Preto, Brazil — _RECRUITING_
- Klinikum Augsburg, Augsburg, Germany — _RECRUITING_
- Berlin Charite Hospital, Berlin, Germany — _RECRUITING_
- Dresden University Hospital, Dresden, Germany — _RECRUITING_
- University Medical Center Mannheim, Mannheim, Germany — _TERMINATED_
- Oberschwabenklinik, Ravensburg, Germany — _TERMINATED_
- Bergamo Hospital, Bergamo, Italy — _RECRUITING_
- Genova Hospital, Genoa, Italy — _RECRUITING_
- University Hospital Modena, Modena, Italy — _RECRUITING_
- Santa Corona Hospital, Pietra Ligure, Italy — _RECRUITING_
- Roma Umberto I, Rome, Italy — _WITHDRAWN_
- Varese Hospital, Varese, Italy — _RECRUITING_
- Rijnstate, Arnhem, Gelderland, Netherlands — _SUSPENDED_
- Academic Hospital Maastricht, Maastricht, Limburg, Netherlands — _RECRUITING_
- St. Elisabeth Hospital, Tilburg, North Brabant, Netherlands — _RECRUITING_
- Academic Medical Center, Amsterdam, North Holland, Netherlands — _RECRUITING_
- MCH Westeinde, The Hague, South Holland, Netherlands — _RECRUITING_
- St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands — _RECRUITING_
- University Medical Center Groningen, Groningen, Netherlands — _WITHDRAWN_
- Leiden University Hospital, Leiden, Netherlands — _RECRUITING_
- Erasmus Medical Center, Rotterdam, Netherlands — _RECRUITING_
- Haga Hospital, The Hague, Netherlands — _RECRUITING_
- Universitary Medical Center Utrecht, Utrecht, Netherlands — _RECRUITING_
- University Hospital North Norway, Tromsø, Norway — _RECRUITING_
- St. Olavs Hospital Trondheim, Trondheim, Norway — _RECRUITING_
- University Hospital of Lausanne, Lausanne, Canton of Vaud, Switzerland — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `locations.roma umberto i|rome||italy` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fortaleza general hospital|fortaleza||brazil` — added _(2026-05-12)_
- `locations.hospital das clinicas de ribeirao preto|ribeirão preto||brazil` — added _(2026-05-12)_
- `locations.klinikum augsburg|augsburg||germany` — added _(2026-05-12)_
- `locations.berlin charite hospital|berlin||germany` — added _(2026-05-12)_
- `locations.dresden university hospital|dresden||germany` — added _(2026-05-12)_
- `locations.university medical center mannheim|mannheim||germany` — added _(2026-05-12)_
- `locations.oberschwabenklinik|ravensburg||germany` — added _(2026-05-12)_
- `locations.bergamo hospital|bergamo||italy` — added _(2026-05-12)_
- `locations.genova hospital|genoa||italy` — added _(2026-05-12)_
- `locations.university hospital modena|modena||italy` — added _(2026-05-12)_
- `locations.santa corona hospital|pietra ligure||italy` — added _(2026-05-12)_
- `locations.varese hospital|varese||italy` — added _(2026-05-12)_
- `locations.rijnstate|arnhem|gelderland|netherlands` — added _(2026-05-12)_
- `locations.academic hospital maastricht|maastricht|limburg|netherlands` — added _(2026-05-12)_
- `locations.st. elisabeth hospital|tilburg|north brabant|netherlands` — added _(2026-05-12)_
- `locations.academic medical center|amsterdam|north holland|netherlands` — added _(2026-05-12)_
- `locations.mch westeinde|the hague|south holland|netherlands` — added _(2026-05-12)_
- `locations.st. antonius hospital|nieuwegein|utrecht|netherlands` — added _(2026-05-12)_
- `locations.university medical center groningen|groningen||netherlands` — added _(2026-05-12)_
- `locations.leiden university hospital|leiden||netherlands` — added _(2026-05-12)_
- `locations.erasmus medical center|rotterdam||netherlands` — added _(2026-05-12)_
- `locations.haga hospital|the hague||netherlands` — added _(2026-05-12)_
- `locations.universitary medical center utrecht|utrecht||netherlands` — added _(2026-05-12)_
- `locations.university hospital north norway|tromsø||norway` — added _(2026-05-12)_
- `locations.st. olavs hospital trondheim|trondheim||norway` — added _(2026-05-12)_
- `locations.university hospital of lausanne|lausanne|canton of vaud|switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01717755.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01717755*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*