SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (SWIFT)

• ClinicalTrials.gov Identifier: NCT01054560
• Recruitment Status: Completed
• First Posted: January 22, 2010
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Sponsor: Medtronic Neurovascular Clinical Affairs
• Information provided by (Responsible Party): Medtronic Neurovascular Clinical Affairs

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ischemic Stroke
• Interventions: Device: SOLITAIRE™ Device; Device: MERCI® Device
• Enrollment: 144

Participant Flow

Recruitment Details	Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.
Pre-assignment Details	Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Period Title: Overall Study
Started	58	55
Completed	45	27
Not Completed	13	28
Reason Not Completed
Death	10	21
Lost to Follow-up	2	5
Withdrawal by Subject	0	2
Physician Decision	1	0

Baseline Characteristics

Arm/Group Title		SOLITAIRE™ Device	MERCI® Device	Total
Arm/Group Description		The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.	Total of all reporting groups
Overall Number of Baseline Participants		58	55	113
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	55 participants	113 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	22 37.9%	22 40.0%	44 38.9%
	>=65 years	36 62.1%	33 60.0%	69 61.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	58 participants	55 participants	113 participants
		67.1 (12.0)	67.1 (11.1)	67.1 (11.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	55 participants	113 participants
	Female	30 51.7%	27 49.1%	57 50.4%
	Male	28 48.3%	28 50.9%	56 49.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	58 participants	55 participants	113 participants
United States		57	54	111
Europe		1	1	2

Outcome Measures

1. Primary Outcome

Title	Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Description	Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)
Time Frame	Immediately post treatment

Outcome Measure Data

Analysis Population Description

Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	56	54
Measure Type: Number; Unit of Measure: Percent of Subjects
	60.7	24.1

2. Primary Outcome

Title	Study Device-related Serious Adverse Events (SAEs)
Description	Incidence of study device-related Serious Adverse Events (SAEs)
Time Frame	90 Day

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	58	55
Measure Type: Number; Unit of Measure: percentage of subjects
	9	16

3. Primary Outcome

Title	Procedure-related Serious Adverse Events (SAEs)
Description	Incidence of study procedure-related Serious Adverse Events (SAEs)
Time Frame	90 Day

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	58	55
Measure Type: Number; Unit of Measure: percentage of subjects
	14	16

4. Secondary Outcome

Title	Time to Initial Recanalization
Description	Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
Time Frame	post treatment

Outcome Measure Data

Analysis Population Description

Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	47	46
Mean (Standard Deviation); Unit of Measure: minutes
	47 (37.3)	58.7 (33.8)

5. Secondary Outcome

Title	Good Neurological Outcome at 30 Days
Description	Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time Frame	30 Days Follow-up

Outcome Measure Data

Analysis Population Description

Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	55	51
Measure Type: Number; Unit of Measure: Percent of subjects
	50.9	33.3

6. Secondary Outcome

Title	Good Neurological Outcome 90 Days
Description	Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time Frame	90 Days Follow-up

Outcome Measure Data

Analysis Population Description

Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	55	48
Measure Type: Number; Unit of Measure: Percent of subjects
	58.2	33.3

7. Secondary Outcome

Title	Mortality
Description	Rate of Mortality
Time Frame	90 Days follow-up

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	58	55
Measure Type: Number; Unit of Measure: Percentage of subjects
	17.2	38.2

8. Secondary Outcome

Title	Symptomatic Intracranial Hemorrhage
Description	Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	58	55
Measure Type: Number; Unit of Measure: Percentage of subjects
	1.7	10.9

9. Secondary Outcome

Title	Non-fatal Stroke-related Morbidity
Description	Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events
Time Frame	90 Day

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	SOLITAIRE™ Device	MERCI® Device
Arm/Group Description:	SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed	58	55
Measure Type: Number; Unit of Measure: percentage of subjects
	43.1	32.7

Adverse Events

Time Frame	90 Days
Adverse Event Reporting Description	Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Arm/Group Title	The SOLITAIRE™ Device		The MERCI® Device
Arm/Group Description	The SOLITAIRE™ Device (investigational device) is the experimental arm		The MERCI® Device (control device) is commercially available.
All-Cause Mortality
	The SOLITAIRE™ Device		The MERCI® Device
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	The SOLITAIRE™ Device		The MERCI® Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/58 (84.48%)		44/55 (80.00%)
Blood and lymphatic system disorders
Anaemia † 1	9/58 (15.52%)	10	4/55 (7.27%)	4
Thrombocytopenia † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Disseminated Intravascular Coagulation † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cardiac disorders
Atrial Fibrillation † 1	11/58 (18.97%)	12	4/55 (7.27%)	4
Atrial Flutter † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Artrioventricular block † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Bradycardyia † 1	1/58 (1.72%)	1	2/55 (3.64%)	2
Bundle branch block right † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Cardiac disorders † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Cardiac failure congestive † 1	2/58 (3.45%)	2	1/55 (1.82%)	1
Tachycardia † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Ventricular tachycardia † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Acute myocardial † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Arrhythmia † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cardiac arrest † 1	0/58 (0.00%)	0	3/55 (5.45%)	4
Mitral valve disease † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Sinus bradycardia † 1	0/58 (0.00%)	0	2/55 (3.64%)	2
Supraventricular tachycardia † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cardiomyopathy † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Eye disorders
Retinal Artery Occlusion † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Vitreous detachment † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Gastrointestinal disorders
Colitis † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Dysphagia † 1	1/58 (1.72%)	1	4/55 (7.27%)	4
Gastrointestinal haemorrhage † 1	1/58 (1.72%)	1	1/55 (1.82%)	2
Gastrointestinal ulcer † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Haematemesis † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Haematochezia † 1	2/58 (3.45%)	2	0/55 (0.00%)	0
Intestinal ischaemia † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Nausea † 1	0/58 (0.00%)	0	3/55 (5.45%)	3
Retroperitoneal haematoma † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
General disorders
Catheter site haematoma † 1	2/58 (3.45%)	2	0/55 (0.00%)	0
Device breakage † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Multi-organ failure † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Pyrexia † 1	3/58 (5.17%)	3	3/55 (5.45%)	3
Catheter Site Haemorrhage † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Hepatobiliary disorders
Cholecystitis acute † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cholecystitis † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Infections and infestations
Wound infection † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Urinary tract infection † 1	3/58 (5.17%)	3	6/55 (10.91%)	6
Tracheobronchitis † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Sepsis † 1	3/58 (5.17%)	3	2/55 (3.64%)	2
Pneumonia † 1	2/58 (3.45%)	2	5/55 (9.09%)	5
Infusion site infection † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Febrile infection † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Clostridal infection † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Bacterial disease carrier † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Bacteraemia † 1	1/58 (1.72%)	1	2/55 (3.64%)	2
Injury, poisoning and procedural complications
Vascular access complication † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Procedural hypertension † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Femoral nerve injury † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Toxicity to various agents † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Investigations
Heart rate irregular † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Electrocardiogram abnormal † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Echocardiogram abnormal † 1	2/58 (3.45%)	2	0/55 (0.00%)	0
Lipids increased † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Breath sounds abnormal † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Blood creatinine † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Metabolism and nutrition disorders
Hypoglycaemia † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Fluid overload † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Hypernatraemia † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Malnutrition † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Pain in extremity † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Nervous system disorders
Brain oedema † 1	2/58 (3.45%)	2	1/55 (1.82%)	1
Carotid artery dissection † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Carotid artery stenosis † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cerebral artery occlusion † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Cerebral gas embolism † 1	1/58 (1.72%)	1	3/55 (5.45%)	3
Cerebral haematoma † 1	5/58 (8.62%)	5	8/55 (14.55%)	8
Cerebrovascular accident † 1	7/58 (12.07%)	7	13/55 (23.64%)	13
Cerebrovascular spasm † 1	3/58 (5.17%)	3	4/55 (7.27%)	4
Convulsion † 1	0/58 (0.00%)	0	2/55 (3.64%)	2
Depressed level of consciousness † 1	0/58 (0.00%)	0	2/55 (3.64%)	2
Encephalopathy † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Haemorrhagic cerebral infarction † 1	4/58 (6.90%)	4	3/55 (5.45%)	3
Intracranial pressure increased † 1	2/58 (3.45%)	2	2/55 (3.64%)	2
Intraventricular haemorrhage † 1	2/58 (3.45%)	2	2/55 (3.64%)	2
Ischaemic stroke † 1	2/58 (3.45%)	2	7/55 (12.73%)	7
Lethargy † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Subarachnoid haemorrhage † 1	3/58 (5.17%)	3	7/55 (12.73%)	7
Syncope † 1	1/58 (1.72%)	1	1/55 (1.82%)	1
Tremor † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Psychiatric disorders
Agitation † 1	2/58 (3.45%)	2	0/55 (0.00%)	0
Confusional state † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Renal and urinary disorders
Haematuria † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Hydronephrosis † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Renal failure † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Renal failure acute † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Urinary retention † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/58 (1.72%)	1	2/55 (3.64%)	2
Atelectasis † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Hypoxia † 1	4/58 (6.90%)	4	1/55 (1.82%)	1
Increased bronchial secretion † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Lung infiltration † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Pleural effusion † 1	0/58 (0.00%)	0	3/55 (5.45%)	3
Pneumonia aspiration † 1	6/58 (10.34%)	6	3/55 (5.45%)	3
Productive cough † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Pulmonary embolism † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Pulmonary Oedema † 1	2/58 (3.45%)	2	5/55 (9.09%)	5
Respiratory failure † 1	5/58 (8.62%)	5	8/55 (14.55%)	8
Vascular disorders
Air embolism † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Deep vein thrombosis † 1	3/58 (5.17%)	3	2/55 (3.64%)	2
Femoral artery occlusion † 1	0/58 (0.00%)	0	1/55 (1.82%)	1
Hypertension † 1	4/58 (6.90%)	4	1/55 (1.82%)	1
Hypertensive crisis † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Hypotension † 1	6/58 (10.34%)	7	5/55 (9.09%)	5
Intra-abdominal haemorrhage † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Peripheral ischaemia † 1	1/58 (1.72%)	1	0/55 (0.00%)	0
Vasospasm † 1	3/58 (5.17%)	3	3/55 (5.45%)	3
Vessel perforation † 1	0/58 (0.00%)	0	2/55 (3.64%)	2
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	The SOLITAIRE™ Device		The MERCI® Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/58 (63.79%)		30/55 (54.55%)
Blood and lymphatic system disorders
Anaemia † 1	3/58 (5.17%)	3	3/55 (5.45%)	3
Thrombocytopenia † 2	3/58 (5.17%)	3	0/55 (0.00%)	0
Cardiac disorders
Bradycardia † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Arrhythmia † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Tachycardia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Cardiac failure congestive † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Sinus Bradycardia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Cardiomegaly † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Left ventricular dysfunction † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Atrial fibrillation † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Endocrine disorders
Inappropriate antidiuretic hormone secretion † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Eye disorders
Conjunctivitis † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Diplopia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Eye oedema † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Gastrointestinal disorders
Nausea † 2	1/58 (1.72%)	1	4/55 (7.27%)	5
Abdominal pain † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Dysphagia † 2	2/58 (3.45%)	2	0/55 (0.00%)	0
Diarrhoea † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Constipation † 2	1/58 (1.72%)	1	2/55 (3.64%)	2
Colitis ulcerative † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Dyspepsia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
General disorders
Adverse drug reaction † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Catheter site haematoma † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Catheter site haemorrhage † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Oedema peripheral † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Pyrexia † 2	4/58 (6.90%)	4	3/55 (5.45%)	3
Unintentional medical device removal by patient † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Infections and infestations
Candidiasis † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Cellulitis † 2	2/58 (3.45%)	2	2/55 (3.64%)	2
Clostridial infection † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Oral candidiasis † 2	2/58 (3.45%)	2	0/55 (0.00%)	0
Pneumonia † 2	0/58 (0.00%)	0	2/55 (3.64%)	2
Urinary tract infection † 2	12/58 (20.69%)	12	6/55 (10.91%)	7
Injury, poisoning and procedural complications
Periorbital haematoma † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Vascular Pseudoaneurysm † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Laceration † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Urinary retention postoperative † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Fall † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Investigations
Blood bilirubin increased † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Blood urea increased † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Differential white blood cell count abnormal † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Ejection fraction decreased † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Laboratory test abnormal † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Low density lipoprotein increased † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Protein total decreased † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Prothrombin time prolonged † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Troponin increased † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Metabolism and nutrition disorders
Electrolyte imbalance † 2	3/58 (5.17%)	3	2/55 (3.64%)	2
Fluid overload † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Gout † 2	0/58 (0.00%)	0	2/55 (3.64%)	2
Hyperglycaemia † 2	2/58 (3.45%)	2	4/55 (7.27%)	5
Hypernatraemia † 2	1/58 (1.72%)	1	2/55 (3.64%)	2
Hypocalcaemia † 2	2/58 (3.45%)	2	3/55 (5.45%)	3
Hypokalaemia † 2	0/58 (0.00%)	0	4/55 (7.27%)	5
Hyponatraemia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Hypomagnesaemia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Metabolic acidosis † 2	2/58 (3.45%)	2	1/55 (1.82%)	1
Type 2 diabetes mellitus † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Hypoglycaemia † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 2	2/58 (3.45%)	2	0/55 (0.00%)	0
Back pain † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Groin pain † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Pain in extremity † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Rheumatoid arthritis † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Upper extremity mass † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Musculoskeletal Pain † 2	1/58 (1.72%)	1	2/55 (3.64%)	2
Nervous system disorders
Brain oedema † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Carotid artery dissection † 2	2/58 (3.45%)	2	0/55 (0.00%)	0
Cerebral haematoma † 2	1/58 (1.72%)	1	2/55 (3.64%)	2
Cerebrovascular accident † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Haemorrhagic cerebral infarction † 2	3/58 (5.17%)	3	2/55 (3.64%)	2
Headache † 2	6/58 (10.34%)	6	2/55 (3.64%)	2
Intracranial pressure increased † 2	2/58 (3.45%)	2	1/55 (1.82%)	1
Intraventricular haemorrhage † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Muscle spasticity † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Subarachnoid haemorrhage † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Psychiatric disorders
Anxiety † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Depression † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Mental status changes † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Renal and urinary disorders
Oliguria † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Haematuria † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Reproductive system and breast disorders
Genital rash † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis † 2	4/58 (6.90%)	4	1/55 (1.82%)	1
Epistaxis † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Hyperventilation † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Hpoxia † 2	2/58 (3.45%)	2	0/55 (0.00%)	0
Lung infiltration † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Pleural effusion † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Pulmonary oedema † 2	1/58 (1.72%)	1	1/55 (1.82%)	1
Respiratory alkalosis † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Respiratory disorder † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Hypoventilation † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash maculo-papular † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Decubitus ulcer † 2	0/58 (0.00%)	0	2/55 (3.64%)	2
Erythema † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Vascular disorders
Deep vein thrombosis † 2	0/58 (0.00%)	0	3/55 (5.45%)	3
Hypertension † 2	2/58 (3.45%)	3	0/55 (0.00%)	0
Hypotension † 2	0/58 (0.00%)	0	1/55 (1.82%)	1
Labile blood pressure † 2	1/58 (1.72%)	1	0/55 (0.00%)	0
Thromophlebitis superficial † 2	0/58 (0.00%)	0	2/55 (3.64%)	2
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (11.0); 2 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Physician shall not make any publication without providing Sponsor 30 days notice.If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.

Results Point of Contact

• Name/Title: Director of Clinical Affairs
• Organization: Covidien
• Phone: 9498373700

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25. Erratum in: J Neurointerv Surg. 2021 Sep;13(9):e21.

Coutinho JM, Liebeskind DS, Slater LA, Nogueira RG, Clark W, Dávalos A, Bonafé A, Jahan R, Fischer U, Gralla J, Saver JL, Pereira VM. Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies. JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374.

Kim JT, Jahan R, Saver JL; SWIFT Investigators. Impact of Glucose on Outcomes in Patients Treated With Mechanical Thrombectomy: A Post Hoc Analysis of the Solitaire Flow Restoration With the Intention for Thrombectomy Study. Stroke. 2016 Jan;47(1):120-7. doi: 10.1161/STROKEAHA.115.010753. Epub 2015 Dec 10.

Sheth SA, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Saver JL; SWIFT Trialists. Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. J Neurointerv Surg. 2016 Apr;8(4):347-52. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12.

Liebeskind DS, Jahan R, Nogueira RG, Zaidat OO, Saver JL; SWIFT Investigators. Impact of collaterals on successful revascularization in Solitaire FR with the intention for thrombectomy. Stroke. 2014 Jul;45(7):2036-40. doi: 10.1161/STROKEAHA.114.004781. Epub 2014 May 29.

Liebeskind DS, Jahan R, Nogueira RG, Jovin TG, Lutsep HL, Saver JL; SWIFT Investigators. Serial Alberta Stroke Program early CT score from baseline to 24 hours in Solitaire Flow Restoration with the Intention for Thrombectomy study: a novel surrogate end point for revascularization in acute stroke. Stroke. 2014 Mar;45(3):723-7. doi: 10.1161/STROKEAHA.113.003914. Epub 2014 Feb 13.

Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.

• Responsible Party: Medtronic Neurovascular Clinical Affairs
• ClinicalTrials.gov Identifier: NCT01054560
• Other Study ID Numbers: SWIFT
• First Submitted: December 10, 2009
• First Posted: January 22, 2010
• Results First Submitted: April 24, 2012
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016