Acute Ischemic StrokePEN-CoolNCT07844096
COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
A study testing PEN-Cool Conductive Head-and-Neck Cooling System and Standard Reperfusion Therapy / Routine Care in people with Acute Ischemic Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 5 sites in India.
Trial summary
This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- PEN-Cool Conductive Head-and-Neck Cooling System and Standard Reperfusion Therapy / Routine Care
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesIndia
- Study dates
- 1 Sep 2027to 30 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHASE l
- Healthy adult participants of any gender aged 18 years or older and able to provide
- informed consent.
- PHASE II
- 1. Adult patients of any gender, presenting with acute ischemic stroke and eligible for reperfusion therapy IVT or EVT or Both as per guidelines.
Who cannot join
- PHASE I
- History of uncontrolled hypertension or cardiovascular disease.
- Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.
- Vasospastic disorders like Raynaud or thromboangiitis obliteran.
- Skin lesions not allowing secure application of the cooling system
- PHASE II
Show all 12Show fewer
- Surface Body temperature less than and equal to 35 degree Celcius at baseline
- Blood pressure more than or equal to 185 by 110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy
- Known contraindications to hypothermia including hemodynamically unstable patients with new or symptomatic bradyarrhythmia known hematologic dyscrasias that affect thrombosis or vasospastic disorders such as Raynaud syndrome or thrombo angiitis obliterans.
- Skin lesions on scalp or neck preventing secure application of the cooling cap.
- Pre-morbid mRS more than or equal to 3
- Patients with known diseases or conditions resulting in an expected life expectancy of less than or equal to 3 months
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
India5 sites
Indian Institute of Technology, Kharagpur-IIT
Kharagpur, West Bengal, 721302
Prof Manjunatha Mahadevappa, 9475329788, mmaha2emb@gmail.com
Amrita Institute of Medical Sciences- Kochi
Kochi, Kerala, 682041
Dr Vivek Nambiar, 8921485541, dr.vivek.in@gmail.com
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
Dr Ivy A Sebastian, 9999464986, ivy29cmc@gmail.com
All India Institute of Medical Sciences- AIIMS
New Delhi, National Capital Territory of Delhi, 110029
Dr Ayush Agarwal, 8193900444, dr.agarwal.ayush@gmail.com
Christian Medical College and Hospital, Vellore
Vellore, Tamil Nadu, 632004
Dr Angel Miraclin, 9488043281, angel_miraclin@yahoo.com
About this study
Official title: A Pilot Randomized Controlled Trial of Conductive COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke outcomes. It complements existing reperfusion therapies offering a scalable neuroprotective option which will have wider implications across diverse healthcare settings.
PHASE I: Technology Development \& Test Bench Optimization (Years 1-2) PHASE II: Validation in healthy volunteers (Year 3)
PHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):
Read the detailed description
PEN-Cool is a pilot, multicentre, randomized controlled trial evaluating a novel non-invasive active conductive combined head-and-neck cooling system for selective brain cooling in adults with acute ischemic stroke receiving reperfusion therapy. The study is part of a phased translational research programme involving technology development, validation in healthy volunteers, and clinical evaluation in patients with acute ischemic stroke.
The clinical trial will enroll 40 adult patients with acute ischemic stroke who are eligible for intravenous thrombolysis, endovascular thrombectomy, or both. Participants will be centrally randomized in a 1:1 ratio to either adjunctive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone.
In the intervention group, the conductive cooling system will be applied to the scalp and anterolateral and posterolateral neck. Cooling will begin before intravenous thrombolysis and/or endovascular thrombectomy in the emergency department or angiography suite and will continue for up to 120 minutes. The cooling interface will deliver temperatures ranging from -5°C to 0°C. Brain temperature will be monitored non-invasively using infrared tympanic membrane thermometry, while core body temperature will be monitored using a rectal or esophageal probe. Blood pressure, heart rate, and oxygen saturation will also be monitored.
Cooling will be discontinued if predefined safety or tolerability criteria are met, including intolerance, persistent cold-related shivering despite passive warming, core body temperature of 35°C or below, uncontrolled hypertension, symptomatic bradycardia or other unexpected medical events, or procedural complications.
The primary feasibility outcome is adherence to the cooling intervention, defined as receiving head cooling for at least 60% of the intended total cooling duration. Secondary feasibility outcomes include interruptions in cooling and monthly enrollment rate. Efficacy outcomes include early neurological improvement, defined as a 30% or greater improvement in NIHSS score at 24 hours, and good functional outcome, defined as a modified Rankin Scale score of 0-2 at 3 months. Safety outcomes include symptomatic bradyarrhythmia, uncontrolled hypertension, cold-related shivering, cervical or cerebral vasospasm requiring intra-arterial vasodilators, symptomatic intracranial hemorrhage, pneumonia, and mortality through 3 months. Process outcomes include time from hospital arrival to initiation of cooling and time from arrival to reperfusion therapy.
The study will assess whether selective brain cooling can be safely and feasibly integrated into acute ischemic stroke care without delaying established reperfusion workflows and will generate preliminary safety, feasibility, and efficacy data to inform a future adequately powered multicentre randomized controlled trial.
- Conditions
- Acute Ischemic Stroke
- Being tested
- PEN-Cool Conductive Head-and-Neck Cooling System, Standard Reperfusion Therapy / Routine Care
- Keywords
- Acute Ischemic Stroke, Selective brain cooling, Conductive cooling, PEN-Cool, Therapeutic hypothermia, Neuroprotection, Ischemic penumbra, Reperfusion therapy, Intravenous thrombolysis, Endovascular thrombectomy, Head and neck cooling
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEN-Cool Conductive Head-and-Neck Cooling SystemDevice
A novel non-invasive active conductive combined head-and-neck cooling system designed to induce selective brain cooling while avoiding systemic hypothermia.Cooling will begin before IVT and/or EVT in the emergency department or angiography suite and continue for up to 120 minutes. The cooling system will contact the scalp and anterolateral and posterolateral neck and deliver temperatures ranging from -5°C to 0°C. Brain and core temperatures and physiological parameters will be monitored throughout the cooling period along with standard reperfusion.
Standard Reperfusion Therapy / Routine CareOther
Standard of care management for acute ischemic stroke according to institutional practice, including intravenous thrombolysis, endovascular thrombectomy, or both when indicated.
| Study group | Role | What they receive |
|---|---|---|
| Selective Brain Cooling + Standard Reperfusion Therapy | Experimental | Participants will receive adjunctive non-invasive selective brain cooling using the novel active conductive combined head-and-neck cooling system in addition to standard reperfusion therapy (intravenous thrombolysis, endovascular thrombectomy, or both). Receives: Device: PEN-Cool Conductive Head-and-Neck Cooling System |
| Standard Reperfusion Therapy / Routine Care | Active comparator | Participants will receive standard of care management for acute ischemic stroke according to institutional practice, including indicated intravenous thrombolysis and/or endovascular thrombectomy, without selective brain cooling. Receives: Other: Standard Reperfusion Therapy / Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intervention cooling system.
Phase III (Feasibility outcomes) Primary feasibility outcome defined as the proportion of participants who will be adherent to the intervention. Adherence defined as undergoing head cooling for more than equal to 60 percent of the total time from the first application of the head and neck cooling system.
Measured: 3 months
Secondary outcomes (4)
Interruption of cooling system
PHASE III Secondary feasibility outcomes include interruption of cooling and the monthly enrollment rate.
High recrutements are good outcome.
Measured: 3 months
NIHSS
Phase III Efficacy outcomes: Early neurological improvement, defined as a 30% or greater improvement in the NIHSS score at 24 h.
Lower NIHSS is good outcome
Measured: 24 hours
mRS
Phase III Good functional outcome at 3 months Good functional outcome, defined as an mRS of 0, 1, or 2, at 3 months assessed by telephone interview conducted by a trained researcher. Lower mRS indicates good outcome.
Measured: 3 months
Safety outcome
Phase III Including bradyarrhythmia, pneumonia, shivering and cerebral vasospasm at 3 months.
Measured: 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 Sep 2026
- Study start1 Sep 2027 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (Phase I) Prospective, single-arm, non-randomized, open-label feasibility and safety study. -Assess device tolerability, safety, and cooling efficacy in healthy volunteers (n=15) under controlled conditions, with continuous monitoring of physiological parameters (Phase III) Multicentre, parallel-group, pilot randomized controlled trial with 1:1 allocation to adjunctive non-invasive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone. Centralized web-based randomization will be used.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Dr Jeyaraj D Pandian, Principal investigator, Christian Medical College and Hospital, Ludhiana, IndiaDr ATUL PHILLIPS, Principal investigator, Christian Medical College and Hospital, Ludhiana, IndiaDr Ivy A Sebastian, Principal investigator, Christian Medical College and Hospital, Ludhiana, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844096
- Sponsor's protocol ID
- PEN-Cool
- Acronym
- PEN-Cool
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers.
Publications
Goyal M, Ospel JM, Ganesh A, Dowlatshahi D, Volders D, Mohlenbruch MA, Jumaa MA, Nimjee SM, Booth TC, Buck BH, Kennedy J, Shankar JJ, Dorn F, Zhang L, Hametner C, Nardai S, Zafar A, Diprose W, Vatanpour S, Stebner A, Bosshart S, Singh N, Sebastian I, Uchida K, Ryckborst KJ, Fahed R, Hu SX, Vollherbst DF, Zaidi SF, Lee VH, Lynch J, Rempel JL, Teal R, Trivedi A, Bode FJ, Ogungbemi A, Pham M, Orosz P, Abdalkader M, Taschner C, Tarpley J, Poli S, Singh RJ, De Leacy R, Lopez G, Sahlas D, Chen M, Burns P, Schaafsma JD, Marigold R, Reich A, Amole A, Field TS, Swartz RH, Settecase F, Lenzser G, Ortega-Gutierrez S, Asdaghi N, Lobotesis K, Siddiqui AH, Berrouschot J, Mokin M, Ebersole K, Schneider H, Yoo AJ, Mandzia J, Klostranec J, Jadun C, Patankar T, Sauvageau E, Lenthall R, Peeling L, Huynh T, Budzik R, Lee SK, Makalanda L, Levitt MR, Perry RJ, Hlaing T, Jahromi BS, Singh P, Demchuk AM, Hill MD; ESCAPE-MeVO Investigators. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion. N Engl J Med. 2025 Apr 10;392(14):1385-1395. doi: 10.1056/NEJMoa2411668. Epub 2025 Feb 5.
PubMed 39908448Pandian JD, Sylaja PN, Lackland DT, Babu V, Kumar Paramasivan N, Sebastian I, Parati G, Anderson CS, Ovbiagele B, Fisher M, Martins S, Whelton P. World Stroke Organization and World Hypertension League position statement on hypertension control strategies in prevention and management of stroke. Int J Stroke. 2025 Feb;20(2):151-165. doi: 10.1177/17474930241309276. Epub 2025 Jan 3.
PubMed 39670456Pandian JD, Kalkonde Y, Sebastian IA, Felix C, Urimubenshi G, Bosch J. Stroke systems of care in low-income and middle-income countries: challenges and opportunities. Lancet. 2020 Oct 31;396(10260):1443-1451. doi: 10.1016/S0140-6736(20)31374-X.
PubMed 33129395Sebastian IA, Gandhi DBC, Sylaja PN, Paudel R, Kalkonde YV, Yangchen Y, Gunasekara H, Injety RJ, Vijayanand PJ, Chawla NS, Oo S, Hla KM, Tenzin T, Pandian JD. Stroke systems of care in South-East Asia Region (SEAR): commonalities and diversities. Lancet Reg Health Southeast Asia. 2023 Oct 9;17:100289. doi: 10.1016/j.lansea.2023.100289. eCollection 2023 Oct.
PubMed 37849930Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
PubMed 34414293
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Conductive COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT07844096
- Acronym / sponsor ID
- PEN-Cool / PEN-Cool
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Selective brain cooling, Conductive cooling, PEN-Cool, Therapeutic hypothermia, Neuroprotection, Ischemic penumbra, Reperfusion therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 30 Aug 2031 (estimated)
- Study completion
- 30 Aug 2031 (estimated)
- First posted
- 28 Sep 2026 (actual)
- 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.
This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke outcomes. It complements existing reperfusion therapies offering a scalable neuroprotective option which will have wider implications across diverse healthcare settings.
PHASE I: Technology Development \& Test Bench Optimization (Years 1-2) PHASE II: Validation in healthy volunteers (Year 3)
PHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):
Detailed description
PEN-Cool is a pilot, multicentre, randomized controlled trial evaluating a novel non-invasive active conductive combined head-and-neck cooling system for selective brain cooling in adults with acute ischemic stroke receiving reperfusion therapy. The study is part of a phased translational research programme involving technology development, validation in healthy volunteers, and clinical evaluation in patients with acute ischemic stroke.
The clinical trial will enroll 40 adult patients with acute ischemic stroke who are eligible for intravenous thrombolysis, endovascular thrombectomy, or both. Participants will be centrally randomized in a 1:1 ratio to either adjunctive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone.
In the intervention group, the conductive cooling system will be applied to the scalp and anterolateral and posterolateral neck. Cooling will begin before intravenous thrombolysis and/or endovascular thrombectomy in the emergency department or angiography suite and will continue for up to 120 minutes. The cooling interface will deliver temperatures ranging from -5°C to 0°C. Brain temperature will be monitored non-invasively using infrared tympanic membrane thermometry, while core body temperature will be monitored using a rectal or esophageal probe. Blood pressure, heart rate, and oxygen saturation will also be monitored.
Cooling will be discontinued if predefined safety or tolerability criteria are met, including intolerance, persistent cold-related shivering despite passive warming, core body temperature of 35°C or below, uncontrolled hypertension, symptomatic bradycardia or other unexpected medical events, or procedural complications.
The primary feasibility outcome is adherence to the cooling intervention, defined as receiving head cooling for at least 60% of the intended total cooling duration. Secondary feasibility outcomes include interruptions in cooling and monthly enrollment rate. Efficacy outcomes include early neurological improvement, defined as a 30% or greater improvement in NIHSS score at 24 hours, and good functional outcome, defined as a modified Rankin Scale score of 0-2 at 3 months. Safety outcomes include symptomatic bradyarrhythmia, uncontrolled hypertension, cold-related shivering, cervical or cerebral vasospasm requiring intra-arterial vasodilators, symptomatic intracranial hemorrhage, pneumonia, and mortality through 3 months. Process outcomes include time from hospital arrival to initiation of cooling and time from arrival to reperfusion therapy.
The study will assess whether selective brain cooling can be safely and feasibly integrated into acute ischemic stroke care without delaying established reperfusion workflows and will generate preliminary safety, feasibility, and efficacy data to inform a future adequately powered multicentre randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (Phase I) Prospective, single-arm, non-randomized, open-label feasibility and safety study. -Assess device tolerability, safety, and cooling efficacy in healthy volunteers (n=15) under controlled conditions, with continuous monitoring of physiological parameters (Phase III) Multicentre, parallel-group, pilot randomized controlled trial with 1:1 allocation to adjunctive non-invasive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone. Centralized web-based randomization will be used.
| Arm | Type | Receives |
|---|---|---|
| Selective Brain Cooling + Standard Reperfusion Therapy | Experimental | Device: PEN-Cool Conductive Head-and-Neck Cooling SystemParticipants will receive adjunctive non-invasive selective brain cooling using the novel active conductive combined head-and-neck cooling system in addition to standard reperfusion therapy (intravenous thrombolysis, endovascular thrombectomy, or both). |
| Standard Reperfusion Therapy / Routine Care | Active comparator | Other: Standard Reperfusion Therapy / Routine CareParticipants will receive standard of care management for acute ischemic stroke according to institutional practice, including indicated intravenous thrombolysis and/or endovascular thrombectomy, without selective brain cooling. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PHASE l
- Healthy adult participants of any gender aged 18 years or older and able to provide
- informed consent.
- PHASE II
- 1. Adult patients of any gender, presenting with acute ischemic stroke and eligible for reperfusion therapy IVT or EVT or Both as per guidelines.
Key exclusion criteria (12 listed)
- PHASE I
- History of uncontrolled hypertension or cardiovascular disease.
- Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.
- Vasospastic disorders like Raynaud or thromboangiitis obliteran.
- Skin lesions not allowing secure application of the cooling system
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 |
|---|---|---|
| PEN-Cool Conductive Head-and-Neck Cooling SystemA novel non-invasive active conductive combined head-and-neck cooling system designed to induce selective brain cooling while avoiding systemic hypothermia.Cooling will begin before IVT and/or EVT in the emergency department or angiography suite and continue for up to 120 minutes. The cooling system will contact the scalp and anterolateral and posterolateral neck and deliver temperatures ranging from -5°C to 0°C. Brain and core temperatures and physiological parameters will be monitored throughout the cooling period along with standard reperfusion. | Device | Selective Brain Cooling + Standard Reperfusion Therapy |
| Standard Reperfusion Therapy / Routine CareStandard of care management for acute ischemic stroke according to institutional practice, including intravenous thrombolysis, endovascular thrombectomy, or both when indicated. | Other | Standard Reperfusion Therapy / Routine Care |
Primary outcome
Adherence to the intervention cooling system.
Time frame: 3 months
Phase III (Feasibility outcomes) Primary feasibility outcome defined as the proportion of participants who will be adherent to the intervention. Adherence defined as undergoing head cooling for more than equal to 60 percent of the total time from the first application of the head and neck cooling system.
4 secondary outcomes
Interruption of cooling system
Time frame: 3 months
NIHSS
Time frame: 24 hours
mRS
Time frame: 3 months
Safety outcome
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Results publication: PubMed 39908448Goyal M, Ospel JM, Ganesh A, Dowlatshahi D, Volders D, Mohlenbruch MA, Jumaa MA, Nimjee SM, Booth TC, Buck BH, Kennedy J, Shankar JJ, Dorn F, Zhang L, Hametner C, Nardai S, Zafar A, Diprose W, Vatanpour S, Stebner A, Bosshart S, Singh N, Sebastian I, Uchida K, Ryckborst KJ, Fahed R, Hu SX, Vollherbst DF, Zaidi SF, Lee VH, Lynch J, Rempel JL, Teal R, Trivedi A, Bode FJ, Ogungbemi A, Pham M, Orosz P, Abdalkader M, Taschner C, Tarpley J, Poli S, Singh RJ, De Leacy R, Lopez G, Sahlas D, Chen M, Burns P, Schaafsma JD, Marigold R, Reich A, Amole A, Field TS, Swartz RH, Settecase F, Lenzser G, Ortega-Gutierrez S, Asdaghi N, Lobotesis K, Siddiqui AH, Berrouschot J, Mokin M, Ebersole K, Schneider H, Yoo AJ, Mandzia J, Klostranec J, Jadun C, Patankar T, Sauvageau E, Lenthall R, Peeling L, Huynh T, Budzik R, Lee SK, Makalanda L, Levitt MR, Perry RJ, Hlaing T, Jahromi BS, Singh P, Demchuk AM, Hill MD; ESCAPE-MeVO Investigators. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion. N Engl J Med. 2025 Apr 10;392(14):1385-1395. doi: 10.1056/NEJMoa2411668. Epub 2025 Feb 5.
- Results publication: PubMed 39670456Pandian JD, Sylaja PN, Lackland DT, Babu V, Kumar Paramasivan N, Sebastian I, Parati G, Anderson CS, Ovbiagele B, Fisher M, Martins S, Whelton P. World Stroke Organization and World Hypertension League position statement on hypertension control strategies in prevention and management of stroke. Int J Stroke. 2025 Feb;20(2):151-165. doi: 10.1177/17474930241309276. Epub 2025 Jan 3.
- Results publication: PubMed 33129395Pandian JD, Kalkonde Y, Sebastian IA, Felix C, Urimubenshi G, Bosch J. Stroke systems of care in low-income and middle-income countries: challenges and opportunities. Lancet. 2020 Oct 31;396(10260):1443-1451. doi: 10.1016/S0140-6736(20)31374-X.
- Results publication: PubMed 37849930Sebastian IA, Gandhi DBC, Sylaja PN, Paudel R, Kalkonde YV, Yangchen Y, Gunasekara H, Injety RJ, Vijayanand PJ, Chawla NS, Oo S, Hla KM, Tenzin T, Pandian JD. Stroke systems of care in South-East Asia Region (SEAR): commonalities and diversities. Lancet Reg Health Southeast Asia. 2023 Oct 9;17:100289. doi: 10.1016/j.lansea.2023.100289. eCollection 2023 Oct.
- Results publication: PubMed 34414293Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers.
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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.
Dr Jeyaraj D Pandian principal investigator
Christian Medical College and Hospital, Ludhiana, India
Dr ATUL PHILLIPS principal investigator
Christian Medical College and Hospital, Ludhiana, India
Dr Ivy A Sebastian principal investigator
Christian Medical College and Hospital, Ludhiana, India
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEN-Cool Conductive Head-and-Neck Cooling System and Standard Reperfusion Therapy / Routine Care in people with Acute Ischemic Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 5 sites in India.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ivy A Sebastian (9999464986, ivy29cmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the intervention cooling system. (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 NCT07844096, which also lists 5 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 28 Sep 2026.