StrokePhase 2NCT01133223
Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke
A Phase 2 study testing Penumbra™ System and Recombinant tissue plasminogen activator in people with Stroke, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Penumbra™ System and Recombinant tissue plasminogen activator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient enrolled in acute ischemic stroke protocol
- Up to 3,5h from symptoms onset
- Clinical findings compatible with middle cerebral artery syndrome
- Angiotomographic evidence of proximal middle cerebral artery occlusion
Who cannot join
- NIHSS < 10
- Overt contraindication to thrombolysis or angiopgraphy
- Disagreement with informed consent term or refusal to participate
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.
- Conditions
- Stroke
- Being tested
- Penumbra™ System, Recombinant tissue plasminogen activator
- Keywords
- Stroke, mecanical thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra™ SystemDevice
Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)
Recombinant tissue plasminogen activatorDrug
Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy | Active comparator | Not described Receives: Device: Penumbra™ System |
| Usual Care | Active comparator | Not described Receives: Drug: Recombinant tissue plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence (modified Rankin Scale 0-2)
Measured: 3 months
Secondary outcomes (3)
Minimal or no disability (modified Rankin Scale 0-1)
Measured: 3 months
Overall mortality
Measured: 7 days and 3 months
Symptomatic cerebral bleeding rate
Measured: 48 hours, 7 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2015
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre
- Investigators
- Sheila Cristina Ouriques Martins, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133223
- Sponsor's protocol ID
- GPPG 09-587
- Status last verified
- Sep 2015
- First submitted
- 26 May 2010
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
PubMed 18815396Ernst R, Pancioli A, Tomsick T, Kissela B, Woo D, Kanter D, Jauch E, Carrozzella J, Spilker J, Broderick J. Combined intravenous and intra-arterial recombinant tissue plasminogen activator in acute ischemic stroke. Stroke. 2000 Nov;31(11):2552-7. doi: 10.1161/01.str.31.11.2552.
PubMed 11062274Wolpert SM, Bruckmann H, Greenlee R, Wechsler L, Pessin MS, del Zoppo GJ. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. The rt-PA Acute Stroke Study Group. AJNR Am J Neuroradiol. 1993 Jan-Feb;14(1):3-13.
PubMed 8427107Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.
PubMed 18096842Agarwal P, Kumar S, Hariharan S, Eshkar N, Verro P, Cohen B, Sen S. Hyperdense middle cerebral artery sign: can it be used to select intra-arterial versus intravenous thrombolysis in acute ischemic stroke? Cerebrovasc Dis. 2004;17(2-3):182-90. doi: 10.1159/000075789. Epub 2003 Dec 29.
PubMed 14707420Noser EA, Shaltoni HM, Hall CE, Alexandrov AV, Garami Z, Cacayorin ED, Song JK, Grotta JC, Campbell MS 3rd. Aggressive mechanical clot disruption: a safe adjunct to thrombolytic therapy in acute stroke? Stroke. 2005 Feb;36(2):292-6. doi: 10.1161/01.STR.0000152331.93770.18. Epub 2004 Dec 29.
PubMed 15625300Berlis A, Lutsep H, Barnwell S, Norbash A, Wechsler L, Jungreis CA, Woolfenden A, Redekop G, Hartmann M, Schumacher M. Mechanical thrombolysis in acute ischemic stroke with endovascular photoacoustic recanalization. Stroke. 2004 May;35(5):1112-6. doi: 10.1161/01.STR.0000124126.17508.d3. Epub 2004 Mar 11.
PubMed 15017011Schumacher HC, Meyers PM, Yavagal DR, Harel NY, Elkind MS, Mohr JP, Pile-Spellman J. Endovascular mechanical thrombectomy of an occluded superior division branch of the left MCA for acute cardioembolic stroke. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):305-8. doi: 10.1007/s00270-003-2719-5.
PubMed 14562985Kulcsar Z, Bonvin C, Pereira VM, Altrichter S, Yilmaz H, Lovblad KO, Sztajzel R, Rufenacht DA. Penumbra system: a novel mechanical thrombectomy device for large-vessel occlusions in acute stroke. AJNR Am J Neuroradiol. 2010 Apr;31(4):628-33. doi: 10.3174/ajnr.A1924. Epub 2009 Dec 17.
PubMed 20019113Bose A, Henkes H, Alfke K, Reith W, Mayer TE, Berlis A, Branca V, Sit SP; Penumbra Phase 1 Stroke Trial Investigators. The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism. AJNR Am J Neuroradiol. 2008 Aug;29(7):1409-13. doi: 10.3174/ajnr.A1110. Epub 2008 May 22.
PubMed 18499798
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study
- ClinicalTrials.gov ID
- NCT01133223
- Acronym / sponsor ID
- GPPG 09-587
- Conditions
- Stroke
- Keywords
- Stroke, mecanical thrombectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy | Active comparator | Device: Penumbra™ System |
| Usual Care | Active comparator | Drug: Recombinant tissue plasminogen activator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient enrolled in acute ischemic stroke protocol
- Up to 3,5h from symptoms onset
- Clinical findings compatible with middle cerebral artery syndrome
- Angiotomographic evidence of proximal middle cerebral artery occlusion
Key exclusion criteria (3 listed)
- NIHSS < 10
- Overt contraindication to thrombolysis or angiopgraphy
- Disagreement with informed consent term or refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penumbra™ SystemPatients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg) | Device | Thrombectomy |
| Recombinant tissue plasminogen activatorPatients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg) | Drug | Usual Care |
Primary outcome
Functional independence (modified Rankin Scale 0-2)
Time frame: 3 months
3 secondary outcomes
Minimal or no disability (modified Rankin Scale 0-1)
Time frame: 3 months
Overall mortality
Time frame: 7 days and 3 months
Symptomatic cerebral bleeding rate
Time frame: 48 hours, 7 days and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Background: PubMed 18815396Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
- Background: PubMed 11062274Ernst R, Pancioli A, Tomsick T, Kissela B, Woo D, Kanter D, Jauch E, Carrozzella J, Spilker J, Broderick J. Combined intravenous and intra-arterial recombinant tissue plasminogen activator in acute ischemic stroke. Stroke. 2000 Nov;31(11):2552-7. doi: 10.1161/01.str.31.11.2552.
- Background: PubMed 8427107Wolpert SM, Bruckmann H, Greenlee R, Wechsler L, Pessin MS, del Zoppo GJ. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. The rt-PA Acute Stroke Study Group. AJNR Am J Neuroradiol. 1993 Jan-Feb;14(1):3-13.
- Background: PubMed 18096842Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.
- Background: PubMed 14707420Agarwal P, Kumar S, Hariharan S, Eshkar N, Verro P, Cohen B, Sen S. Hyperdense middle cerebral artery sign: can it be used to select intra-arterial versus intravenous thrombolysis in acute ischemic stroke? Cerebrovasc Dis. 2004;17(2-3):182-90. doi: 10.1159/000075789. Epub 2003 Dec 29.
- Background: PubMed 15625300Noser EA, Shaltoni HM, Hall CE, Alexandrov AV, Garami Z, Cacayorin ED, Song JK, Grotta JC, Campbell MS 3rd. Aggressive mechanical clot disruption: a safe adjunct to thrombolytic therapy in acute stroke? Stroke. 2005 Feb;36(2):292-6. doi: 10.1161/01.STR.0000152331.93770.18. Epub 2004 Dec 29.
- Background: PubMed 15017011Berlis A, Lutsep H, Barnwell S, Norbash A, Wechsler L, Jungreis CA, Woolfenden A, Redekop G, Hartmann M, Schumacher M. Mechanical thrombolysis in acute ischemic stroke with endovascular photoacoustic recanalization. Stroke. 2004 May;35(5):1112-6. doi: 10.1161/01.STR.0000124126.17508.d3. Epub 2004 Mar 11.
- Background: PubMed 14562985Schumacher HC, Meyers PM, Yavagal DR, Harel NY, Elkind MS, Mohr JP, Pile-Spellman J. Endovascular mechanical thrombectomy of an occluded superior division branch of the left MCA for acute cardioembolic stroke. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):305-8. doi: 10.1007/s00270-003-2719-5.
- Background: PubMed 20019113Kulcsar Z, Bonvin C, Pereira VM, Altrichter S, Yilmaz H, Lovblad KO, Sztajzel R, Rufenacht DA. Penumbra system: a novel mechanical thrombectomy device for large-vessel occlusions in acute stroke. AJNR Am J Neuroradiol. 2010 Apr;31(4):628-33. doi: 10.3174/ajnr.A1924. Epub 2009 Dec 17.
- Background: PubMed 18499798Bose A, Henkes H, Alfke K, Reith W, Mayer TE, Berlis A, Branca V, Sit SP; Penumbra Phase 1 Stroke Trial Investigators. The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism. AJNR Am J Neuroradiol. 2008 Aug;29(7):1409-13. doi: 10.3174/ajnr.A1110. Epub 2008 May 22.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila Cristina Ouriques Martins, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Penumbra™ System and Recombinant tissue plasminogen activator in people with Stroke, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence (modified Rankin Scale 0-2) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01133223, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.