Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2) | NCT02369848

NCT02369848

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Lithoplasty Treatment	Experimental	Shockwave Lithoplasty System	Device: Shockwave Lithoplasty System

Name	Type	Description	Arm Group Labels	Other Names
Shockwave Lithoplasty System	Device		Lithoplasty Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis		12 months post-procedure
Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)	Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion or distal to the treated lesion after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.	Within 30 days following procedure

Secondary Outcomes

Measure	Description	Time Frame
Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)		12 months
Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants	The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation. The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive PTA therapy) as assessed by quantitative angiography via core lab evaluation.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is able and willing to comply with all assessments in the study.
Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Age of subject is >18.
Rutherford Clinical Category 2, 3, or 4.
Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
Estimated life expectancy >1 year.

Angiographic Inclusion Criteria:

Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
Target lesion reference vessel diameter is between 3.50mm and 7.0mm by visual estimate.
Target zone is ≤150mm in length. Target lesion can be all or part of the 150mm zone.
Target lesion is ≥70% stenosis by investigator via visual estimate.
Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis >50%.
Ability to pass the guidewire across the atherosclerotic lesion.
No evidence of aneurysm or acute or chronic thrombus in target vessel.
Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)

Exclusion Criteria:

Rutherford Clinical Category 5 and 6.
Subject has active infection in the target leg.
Planned major amputation of the target leg (transmetatarsal or higher).
The use of chronic total occlusion (CTO) re-entry devices.
CTOs greater than 80 mm in length.
Any in-stent restenosis within the target zone.
Lesions within 10 mm of ostium of the SFA.
Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
Target lesion within native or synthetic vessel grafts.
History of prior endovascular or surgical procedure on the index limb within the past 30 days.
Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated with Plain old Balloon Angioplasty (POBA) or stent and without complications.
Subject requires treatment of a peripheral lesion on the ipsilateral limb distal and beyond the 150mm target zone at the time of the enrollment/index procedure.
Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or International Normalized Ratio (INR) >1.5.
Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
Subject has known allergy to urethane, nylon, or silicone.
Myocardial infarction within 60 days prior to enrollment.
History of stroke within 60 days prior to enrollment.
History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
History of thrombolytic therapy within two weeks of enrollment.
Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
Subject is pregnant or nursing.
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

Name	Affiliation	Role
Thomas Zeller, MD	Universitäts-Herzzentrum Freiburg & Bad Krozingen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum LKH Graz		Graz			Austria
Hanusch Krankenhaus

ID	Title	Description
FG000	Shockwave Medical Inc. Peripheral Lithoplasty	The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Shockwave Medical Inc. Peripheral Lithoplasty	The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis

Data reflects number for participants who have an evaluable (diagnostic) scheduled or unscheduled duplex ultrasound based on reporting windows and slotting rules in the Statistical Plan. Thirty out of 43 participants achieved target lesion patency.

Posted

Count of Participants

Participants

12 months post-procedure

ID	Title	Description
OG000	Shockwave Medical Inc. Peripheral Lithoplasty	The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Shockwave Medical Inc. Peripheral Lithoplasty	The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases