Clinical trial NCT02369848: Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
Official title: Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up rate.

Detailed description: Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to sixty (60) subjects will be enrolled at up to 8 centers in Europe and New Zealand to yield at least 51 evaluable subjects (assuming a lost-to-follow up rate of 15%).

Subjects will be evaluated at discharge, 30 days, 6 months, and 12 months after enrollment/index procedure.

Primary endpoints include safety and efficacy. Safety is a composite of new-onset Major Adverse Events through 30 days. Efficacy is target lesion patency at 12 months by duplex ultrasound defined as freedom from ≥50% restenosis.

Eligibility criteria: Inclusion Criteria:

1. Subject is able and willing to comply with all assessments in the study.
2. 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.
3. Age of subject is \>18.
4. Rutherford Clinical Category 2, 3, or 4.
5. Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
6. Estimated life expectancy \>1 year.

Angiographic Inclusion Criteria:

1. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
2. 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).
3. Target lesion reference vessel diameter is between 3.50mm and 7.0mm by visual estimate.
4. Target zone is ≤150mm in length. Target lesion can be all or part of the 150mm zone.
5. Target lesion is ≥70% stenosis by investigator via visual estimate.
6. 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%.
7. Ability to pass the guidewire across the atherosclerotic lesion.
8. No evidence of aneurysm or acute or chronic thrombus in target vessel.
9. 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:

1. Rutherford Clinical Category 5 and 6.
2. Subject has active infection in the target leg.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. The use of chronic total occlusion (CTO) re-entry devices.
5. CTOs greater than 80 mm in length.
6. Any in-stent restenosis within the target zone.
7. Lesions within 10 mm of ostium of the SFA.
8. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
9. Target lesion within native or synthetic vessel grafts.
10. History of prior endovascular or surgical procedure on the index limb within the past 30 days.
11. 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.
12. 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.
13. 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.
14. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
15. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
16. Subject has known allergy to urethane, nylon, or silicone.
17. Myocardial infarction within 60 days prior to enrollment.
18. History of stroke within 60 days prior to enrollment.
19. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
20. History of thrombolytic therapy within two weeks of enrollment.
21. 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.
22. Subject is pregnant or nursing.
23. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
24. 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.

Primary outcomes:
measure: Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis
timeFrame: 12 months post-procedure
measure: Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)
timeFrame: Within 30 days following procedure
Secondary outcomes:
measure: Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)
timeFrame: 12 months
measure: Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants
timeFrame: Day of Procedure
measure: Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.
timeFrame: 6 months
measure: Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.
timeFrame: 12 months
measure: Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.
timeFrame: 6 months
measure: Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.
timeFrame: 12 months
measure: Clinical Success
timeFrame: 6 months
measure: Clinical Success
timeFrame: 12 months
measure: Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum LKH Graz
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg & Bad Krozingen
city: Leipzig
country: Germany
facility: University Leipzig Medical Centre
city: Munster
country: Germany
facility: St. Franziskus Hospital
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Universitäts-Herzzentrum Freiburg & Bad Krozingen
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
References: