## Protocol Section
### Identification Module
**NCT ID:** NCT06437600

**Acronym:** MAGIC

**Brief Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

**Official Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

#### Organization Study ID Info
**ID:** SYSKY-2024-337-01
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2029-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shenzhen Hospital of Southern Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.

**Detailed Description:** This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2.

Study intervention: (1) Participants in the experimental group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMM) after the procedure. (2) Participants in the control group will receive BMM alone.

This study is anticipated to enroll 418 participants, with 209 participants in each group (1:1 ratio).

### Conditions Module

**Conditions:**

- Stroke, Acute Ischemic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 418

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive immediate angioplasty (with or without stenting) for the culprit vessel and the target residual stenosis should be less than 30%. All participants will receive the best medical management (BMM).

**Intervention Names:**

- Procedure: Immediate angioplasty

**Label:** The experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive BMM alone.

**Label:** The control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The experimental group

**Description:** See arm/group descriptions.

**Name:** Immediate angioplasty

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria).

**Measure:** SAFETY OUTCOME: Symptomatic intracranial hemorrhage

**Time Frame:** 24 (±12) hours

**Description:** Mortality at 90 days.

**Measure:** SAFETY OUTCOME: Mortality

**Time Frame:** 90(±7) days

**Description:** Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria).

**Measure:** SAFETY OUTCOME: Any intracranial hemorrhage

**Time Frame:** 24 (±12) hours

#### Primary Outcomes

**Description:** The proportion of the mRS 0-2 at 90 days.

**Measure:** The modified Rankin Scale (mRS) 0-2

**Time Frame:** 90(±7) days

#### Secondary Outcomes

**Description:** The proportion of the mRS of 0-1 at 90 days.

**Measure:** The mRS 0-1

**Time Frame:** 90(±7) days

**Description:** The proportion of the mRS of 0-3 at 90 days.

**Measure:** The mRS 0-3

**Time Frame:** 90(±7) days

**Description:** The distribution of the mRS at 90 days.

**Measure:** The shift analysis of the mRS distribution

**Time Frame:** 90(±7) days

**Description:** The change of NIHSS from baseline to 7 days or discharge (whichever comes first).

**Measure:** The change of National Institute of Health Stroke Scale (NIHSS)

**Time Frame:** 7(±1) days or discharge, whichever came first

**Description:** The value of quality of life (EQ-5D-5L) at 90 days.

**Measure:** The quality of life

**Time Frame:** 90(±7) days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Aged 18 years or older.
2. Diagnosed with AIS and baseline NIHSS ≥6.
3. Pre-stroke mRS ≤2, or mRS \>2 but not related to neurological disease (e.g., amputation, blindness).
4. Time from symptom onset to randomization within 24 hours; the onset time refers to "Last Known Well" (LKW).
5. NCCT/DWI-MRI ASPECTS ≥6.
6. CTA, MRA, or DSA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
7. Signed informed consent.

Exclusion Criteria:

1. Normal diameter of the culprit vessel \<2.0 mm.
2. Hemorrhagic stroke within the past 90 days.
3. Stroke is caused by cerebral vasculitis, arterial inflammatory stenosis, vasospasm, dissection, perforating arteriopathy, and internal capsule warning syndrome.
4. Severe calcification at the site of stenosis, where target residual stenosis \<30% could not be achieved.
5. Stroke caused by cardioembolic origin, but those with only atrial fibrillation but no clear evidence of cardiac thrombosis could still be included in the study.
6. Coagulation disorder with INR\>1.7, use of new oral anticoagulants within the last 48 hours from screening, or use of low molecular weight heparin within the last 24 hours from screening.
7. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
8. Platelet count \<50×10\^9/L.
9. Intracranial hemorrhage confirmed by CT or MRI.
10. Women who are pregnant or breastfeeding.
11. Participation in other clinical trials.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Aortic dissection.
15. Intracranial tumors or arteriovenous malformations.
16. Previous parenchymal organ surgery or biopsy in the last 1 month.
17. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month.
18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yangxinguang0926@163.com

**Name:** Xinguang Yang, MD

**Phone:** 86-20-81332619

**Role:** CONTACT

**Contact 2:**

**Email:** drxjhe@163.com

**Name:** Xiongjun He, MD, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Name:** Yang Xinguang, Ph.D

- **Phone:** 86-20-81332619

- **Role:** CONTACT

***Contact 2:***

- **Name:** Yamei Tang, M.D., PhD.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

**State:** Guangdong

**Zip:** 510120

**Location 2:**

**City:** Shenzhen

**Country:** China

**Facility:** Shenzhen Hospital of Southern Medical University

**State:** Guangdong

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M2400

- Name: Ischemic Stroke

- Relevance: HIGH

- As Found: Stroke, Acute Ischemic

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemic

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000083242

- Term: Ischemic Stroke

- ID: D000007511

- Term: Ischemia

### Misc Info Module

- Version Holder: 2024-05-31
