Trial Outcomes & Findings for Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System (NCT NCT05007925)
NCT ID: NCT05007925
Last Updated: 2025-08-05
Results Overview
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
30 days
Results posted on
2025-08-05
Participant Flow
Unit of analysis: Lesions
Participant milestones
| Measure |
Disrupt PAD BTK II
Disrupt PAD BTK II: Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
|
|---|---|
|
Overall Study
STARTED
|
250 305
|
|
Overall Study
COMPLETED
|
242 303
|
|
Overall Study
NOT COMPLETED
|
8 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
Baseline characteristics by cohort
| Measure |
Disrupt PAD BTK II
n=250 Participants
Disrupt PAD BTK II: Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
187 Participants
n=5 Participants
|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
239 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The final procedure success at the subject level was 97.9% (232/237). There were five subjects (one subject had both angiographic complications and ≤ 50% residual stenosis) that did not have procedure success. There were three subjects with serious angiographic complications: two subjects had a grade I perforation and one subject had both an abrupt closure and grade F dissection.
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=237 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Number of Participants With Procedure Success
|
232 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: There were two (0.8%, 2/242) MALE events at 30 days that were adjudicated as above-ankle amputations of the index limb. Both major amputations were CEC adjudicated as unplanned amputations unrelated to the study procedure and IVL device. There were no deaths or major reinterventions within 30 days.
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of: * all-cause death * above-ankle amputation of the index limb * major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=242 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
|
2 Participants
|
PRIMARY outcome
Timeframe: 30 daysSubject Success defined as final residual stenosis ≤ 50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab. Serious angiographic complications include (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=237 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Subjects Without Serious Angiographic Complications
|
234 Participants
|
SECONDARY outcome
Timeframe: 30 daysLesion Success defined as final residual stenosis ≤50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=290 Lesions
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Number of Lesions With Technical Success
Lesion Success
|
285 Lesions
|
|
Number of Lesions With Technical Success
Freedom From Any Serious Angiographic Complications
|
287 Lesions
|
|
Number of Lesions With Technical Success
Residual Stenosis ≤ 50%
|
287 Lesions
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPrimary Patency at 6 and 12 months defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: The freedom from CD-TLR endpoint at 30 days post-procedure was 99.6% (242/243).
Clinically-driven target lesion revascularization (CD-TLR) defined as a composite of: * CD-TLR * Major target limb amputation
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=243 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)
|
242 Participants
|
SECONDARY outcome
Timeframe: 30 daysMajor Adverse Events (MAE) at 30 days defined as a composite of: * Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization * Perforations that require an intervention, including bail-out stenting
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=242 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
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|---|---|
|
Number of Participants With Major Adverse Events (MAE)
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6, 12 & 24 monthsThe VascuQoL-6 is a short, disease-specific questionnaire used to measure health-related quality of life (HRQoL) in patients with peripheral arterial disease (PAD), specifically those with intermittent claudication and critical limb ischemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysThe ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=158 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Ankle-brachial Index (ABI) Reported as Change From Baseline
|
0.2 ratio
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 30 daysThe Rutherford classification is a system used to categorize the severity of peripheral artery disease (PAD), specifically chronic limb-threatening ischemia (CLTI), based on symptoms and tissue loss. The classification ranges are from Class 0 where no symptoms of PAD are present and the patient has no claudication or tissue loss to Class 6 where patients have extensive tissue loss, including gangrene, that extends above the transmetatarsal level (the area above the bones of the foot). A higher score on the Rutherford Classification Scale is indicative of a worse outcome.
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=227 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Rutherford Category Reported as Change From Baseline
1-Mild Claudication
|
21 Participants
|
|
Rutherford Category Reported as Change From Baseline
2-Moderate Claudication
|
14 Participants
|
|
Rutherford Category Reported as Change From Baseline
3-Severe Claudication
|
11 Participants
|
|
Rutherford Category Reported as Change From Baseline
4-Ischemic Rest Pain
|
10 Participants
|
|
Rutherford Category Reported as Change From Baseline
5- Minor Tissue Loss
|
102 Participants
|
|
Rutherford Category Reported as Change From Baseline
6-Ulceration Or Gangrene
|
1 Participants
|
|
Rutherford Category Reported as Change From Baseline
0-Asymptomatic
|
68 Participants
|
SECONDARY outcome
Timeframe: 30 DaysThe TBI is the ratio of systolic blood pressure measured at the toe to systolic blood pressure at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=9 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Toe-brachial Index (TBI) Reported as Change From Baseline
|
0.2 ratio
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Freedom from amputation at 30 days was assessed in 242 subjects with two subjects experiencing a major target limb amputation within 30 days of index procedure
Outcome measures
| Measure |
Shockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
n=242 Participants
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Number of Participants Free From Major Target Limb Amputation
|
240 Participants
|
Adverse Events
Disrupt PAD BTK II
Serious events: 67 serious events
Other events: 131 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Disrupt PAD BTK II
n=250 participants at risk
Disrupt PAD BTK II: Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
4/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Atrial fibrillation
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Cardiac arrest
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
General disorders
Chest pain
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
General disorders
Impaired healing
|
2.8%
7/250 • This accounting is for all study events through the 30-day time frame.
|
|
General disorders
Ulcer
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Diabetic foot infection
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Gangrene
|
2.4%
6/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Localised infection
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Necrotising fasciitis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Osteomyelitis
|
3.2%
8/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Pneumonia
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Sepsis
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Septic shock
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Elastic vessel recoil complication
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.6%
4/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
5.2%
13/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Nervous system disorders
Cerebral infarction
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Nervous system disorders
Encephalopathy
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Nervous system disorders
Hypoaesthesia
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
2/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Surgical and medical procedures
Toe amputation
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Dry gangrene
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Haematoma
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Hypertension
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Hypotension
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Intermittent claudication
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.4%
6/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Peripheral embolism
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Peripheral ischemia
|
0.40%
1/250 • This accounting is for all study events through the 30-day time frame.
|
Other adverse events
| Measure |
Disrupt PAD BTK II
n=250 participants at risk
Disrupt PAD BTK II: Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
4/250 • This accounting is for all study events through the 30-day time frame.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
General disorders
Impaired healing
|
2.8%
7/250 • This accounting is for all study events through the 30-day time frame.
|
|
General disorders
Peripheral swelling
|
1.6%
4/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
COVID-19
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Gangrene
|
2.8%
7/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Localised infection
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Osteomyelitis
|
3.2%
8/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Pneumonia
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Infections and infestations
Sepsis
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
6/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.0%
10/250 • This accounting is for all study events through the 30-day time frame.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
23.6%
59/250 • This accounting is for all study events through the 30-day time frame.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Dry gangrene
|
1.2%
3/250 • This accounting is for all study events through the 30-day time frame.
|
|
Vascular disorders
Haematoma
|
1.6%
4/250 • This accounting is for all study events through the 30-day time frame.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60