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Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
NA trial testing Shockwave Lithoplasty® Peripheral Lithoplasty System in Peripheral Arterial Disease in 306 participants. Completed in 2 June 2022.
| Lead sponsor | Shockwave Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 306 |
| Start date | 22 February 2017 |
| Primary completion | 12 May 2020 |
| Estimated completion | 2 June 2022 |
| Sites | 54 locations across Austria, New Zealand, United States, Germany |
Shockwave Medical, Inc. — full company profile →
18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 96 | |
| Medtronic IN.PACT (DCB) | 67 |
* 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
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 0 | |
| Medtronic IN.PACT (DCB) | 2 |
Defined as ankle-brachial index ABI reported at 30 days 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.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | .23 | ± .21 |
| Medtronic IN.PACT (DCB) | .22 | ± .23 |
Defined by Quality of Life assessed by EQ5D questionnaire reported at 30 days as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied. It ranges from 0.000 t
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | .103 | ± .202 |
| Medtronic IN.PACT (DCB) | .116 | ± .184 |
Defined as Rutherford Category reported at 30 days as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | -2.20 | ± 1.08 |
| Medtronic IN.PACT (DCB) | -2.27 | ± .99 |
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI \>20% or \>0.15 when compared to the 30-day ABI and associated with an angiographic lesion \>50% at the target lesion site
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 0 | |
| Medtronic IN.PACT (DCB) | 1 |
* 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
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 0 | |
| Medtronic IN.PACT (DCB) | 2 |
Defined as Rutherford Category reported at 6 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | -2.35 | ± .91 |
| Medtronic IN.PACT (DCB) | -2.29 | ± 1.0 |
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI \>20% or \>0.15 when compared to the 30-day ABI and associated with an angiographic lesion \>50% at the target lesion site
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 4 | |
| Medtronic IN.PACT (DCB) | 1 |
Defined as ankle-brachial index ABI reported at 6 months 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.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | .23 | ± .21 |
| Medtronic IN.PACT (DCB) | .22 | ± .26 |
Defined by Quality of Life assessed by EQ5D questionnaire reported at 6 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | .118 | ± .194 |
| Medtronic IN.PACT (DCB) | .089 | ± .210 |
Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
| Group | Value | 95% CI |
|---|---|---|
| Lithoplasty System Followed by DCB | 99 | |
| Medtronic IN.PACT (DCB) | 87 |
Time frame: Follow-up data was collected through 24 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lithoplasty System Followe… | Medtronic IN.PACT (DCB) |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Peripheral artery restenosis | Vascular disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Intermittent claudication | Vascular disorders | — | — |
| Peripheral arterial occlusive disease | Vascular disorders | — | — |
| Peripheral artery occlusion | Vascular disorders | — | — |
| Peripheral artery stenosis | Vascular disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Cataract | Eye disorders | — | — |
| Angina unstable | Cardiac disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Peripheral arterial reocclusion | Vascular disorders | — | — |
| Peripheral artery dissection | Vascular disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Staphylococcal infection | Infections and infestations | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Skin ulcer | Vascular disorders | — | — |
| Reaction | System | Lithoplasty System Followe… | Medtronic IN.PACT (DCB) |
|---|---|---|---|
| Peripheral arterial occlusive disease | Vascular disorders | — | — |
| Peripheral artery dissection | Vascular disorders | — | — |
| Peripheral artery stenosis | Vascular disorders | — | — |
| Intermittent claudication | Vascular disorders | — | — |
| Peripheral artery restenosis | Vascular disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Peripheral artery occlusion | Vascular disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
Most-reported serious reactions: Pneumonia, Peripheral artery restenosis, Chronic obstructive pulmonary disease, Coronary artery disease, Intermittent claudication, Peripheral arterial occlusive disease, Peripheral artery occlusion, Peripheral artery stenosis.
Data from ClinicalTrials.gov NCT02923193 adverse events section.
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand. In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries. The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing