Trial Outcomes & Findings for Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System (NCT NCT04585763)

Last Updated: 2024-01-03

Results Overview

Defined as: 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

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

30 days

Results posted on

2024-01-03

Participant Flow

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Overall Study STARTED	37 51
Overall Study COMPLETED	35 48
Overall Study NOT COMPLETED	2 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=37 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Age, Continuous	69.7 years STANDARD_DEVIATION 10.2 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	24 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	33 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment New Zealand	17 participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
Region of Enrollment Australia	10 participants n=93 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=37 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Major Adverse Events (MAE)	0 Participants

PRIMARY outcome

Timeframe: Peri-procedural, approximately 2 hours

Population: Technical success is on a per lesion basis, not per subject.

Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=48 Lesions Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Lesions With Technical Success	43 Lesions

SECONDARY outcome

Timeframe: Peri-procedural, approximately 2 hours

Population: IVL Technical Success was calculated on a per lesion basis, not per subject.

Defined as residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion post-IVL by angiographic core lab

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=47 Lesions Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Lesions With IVL Technical Success	28 Lesions

SECONDARY outcome

Timeframe: Peri-procedural, approximately 2 hours

Defined as final residual stenosis ≤30% without any flow-limiting dissection (≥ Grade D) in all target lesions by angiographic core lab

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=35 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Procedural Success	30 Participants

SECONDARY outcome

Timeframe: 30 days

A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography.

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=37 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Improved from baseline

Number of Participants with Improvement in Rutherford Score from as reported at 30 days post-procedure

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=32 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Rutherford Category Reported as Change From Baseline	27 Participants

SECONDARY outcome

Timeframe: 6 months

* 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

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=37 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Major Adverse Events (MAE)	1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=37 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Improved from baseline

Number of Participants with Improvement in Rutherford Score from as reported at 6 months post-procedure

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=34 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Rutherford Category Reported as Change From Baseline	26 Participants

SECONDARY outcome

Timeframe: 12 months

Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram ≥50% stenosis

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=30 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Primary Patency	21 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=35 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Major Adverse Events (MAE)	1 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=35 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)	3 Participants

SECONDARY outcome

Timeframe: 12 months

ABI at 12 months reported as change from baseline. The 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

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=24 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Ankle-brachial Index (ABI) Reported as Change From Baseline	0.3 ratio Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 months

Population: Improved from baseline

Number of Participants with Improvement in Rutherford Score from as reported at 12 Months post-procedure.

Outcome measures

Outcome measures
Measure	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) n=32 Participants Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Rutherford Category Reported as Change From Baseline	24 Participants

Adverse Events

Single Arm

Serious events: 20 serious events

Other events: 36 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=37 participants at risk Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Blood and lymphatic system disorders Neutropenia	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Acute myocardial infarction	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Atrial fibrillation	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Bradycardia	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Cardiac arrest	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Cardiac failure acute	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Pulmonary oedema	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Right ventricular failure	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Cardiac disorders Stress cardiomyopathy	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Gastrointestinal disorders Diarrhoea	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Gastrointestinal disorders Upper gastroinstestinal haemorrhage	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
General disorders Complication of device removal	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Hepatobiliary disorders Cholelithiasis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations Biliary sepsis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations COVID-19	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations Cellulitis	8.1% 3/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations Cholecystitis infective	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations Pyelonephritis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Nephropathy toxic	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Vascular access site occlusion	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Metabolism and nutrition disorders Hypokalaemia	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin squamous cell carcinoma recurrent	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Psychiatric disorders Suicidal ideation	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Renal and urinary disorders Acute kidney injury	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Renal and urinary disorders Haematuria	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Surgical and medical procedures Leg amputation	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Surgical and medical procedures Rehabilitation therapy	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Arterial bypass stenosis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Blue toe syndrome	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Extremity necrosis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Hypotension	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Intermittent claudication	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral arterial occlusive disease	10.8% 4/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery dissection	10.8% 4/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery occlusion	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery stenosis	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral ischaemia	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Retroperitoneal haemorrhage	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Venous ulcer pain	2.7% 1/37 • This accounting is for all study events through the 12 month time frame.

Other adverse events

Other adverse events
Measure	Single Arm n=37 participants at risk Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
Cardiac disorders Atrial fibrillation	8.1% 3/37 • This accounting is for all study events through the 12 month time frame.
Gastrointestinal disorders Diarrhoea	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations COVID-19	13.5% 5/37 • This accounting is for all study events through the 12 month time frame.
Infections and infestations Cellulitis	8.1% 3/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Limb injury	8.1% 3/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Vascular access site haematoma	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Metabolism and nutrition disorders Hypokalaemia	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Hypotension	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Iliac artery dissection	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery restenosis	16.2% 6/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery stenosis	8.1% 3/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Intermittent claudication	27.0% 10/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral arterial occlusive disease	10.8% 4/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Peripheral artery dissection	35.1% 13/37 • This accounting is for all study events through the 12 month time frame.
Vascular disorders Ischemic rest pain	5.4% 2/37 • This accounting is for all study events through the 12 month time frame.

Additional Information

Birgit Greschner

Shockwave Medical

Phone: 650-575-6199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60