Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

Description

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 334 subjects (167 per treatment arm) will be enrolled in the study. 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 250 subjects at the same 50 sites will be enrolled in the observational study.

Study Start Date

February, 22 2017

Estimated Completion Date

April 2020

Interventions

  • Device: Shockwave Lithoplasty® Peripheral Lithoplasty System
  • Drug: Medtronic IN.PACT (DCB)

Study ID

Shockwave Medical, Inc. -- CP 60892

Status

Recruiting

Trial ID

NCT02923193

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

334

Sponsor

Shockwave Medical, Inc.

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 of the target limb. 5. Estimated life expectancy >1 year. 6. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline. 7. Subject is intended to undergo treatment with Lithoplasty followed by DCB or DCB with standard balloon pre-dilatation. Angiographic Inclusion Criteria 8. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal 9. Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate. 10. Target lesion is ?70% stenosis by investigator via visual estimate. 11. Target lesion length is 50-180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone. 12. Chronic total occlusion lesion length is ?100mm. 13. Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%. 14. Calcification is at least moderate defined as 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 0, 1, 5 and 6. 2. Subject has active infection requiring antibiotic therapy. 3. Planned target limb major amputation (above the ankle). 4. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure. 5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter. 6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 7. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 8. Subject has known allergy to urethane, nylon, or silicone. 9. Myocardial infarction within 60 days prior to enrollment. 10.History of stroke within 60 days prior to enrollment. 11.History of thrombolytic therapy within two weeks of enrollment. 12.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. 13.Subject is pregnant or nursing. 14.Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 15.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. 16.The use of specialty balloons, re-entry or atherectomy devices. Angiographic Exclusion Criteria 17.In-stent restenosis within the target zone. 18.Lesions extending from common femoral to superficial femoral artery or within 10 mm of the ostium of the anterior tibial artery. 19.Evidence of aneurysm or thrombus in target vessel. 20.No calcium or mild calcium in the target lesion. 21.Target lesion within native or synthetic vessel grafts. 22.Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated. 23.Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure. 24.Unable to pass the guidewire across the target lesion.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (80)

Study Location Distance Name Phone Email
Steward St Elizabeths Medical Center - Brighton, Maine 2.4 miles Lawrence Garcia None margaret.michaelian@steward.org
Steward St Elizabeths Medical Center - Brighton, Maine 2.4 miles Lawrence Garcia None margaret.michaelian@steward.org
Steward St Elizabeths Medical Center - Brighton, Maine 2.4 miles Lawrence Garcia None margaret.michaelian@steward.org
Steward St Elizabeths Medical Center - Brighton, Maine 2.4 miles Lawrence Garcia None margaret.michaelian@steward.org
Steward St Elizabeths Medical Center - Brighton, Maine 2.4 miles Lawrence Garcia None margaret.michaelian@steward.org
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lina Felix RN None lfelix@lifespan.org
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lina Felix RN None lfelix@lifespan.org
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lina Felix RN None lfelix@lifespan.org
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lina Felix RN None lfelix@lifespan.org
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lina Felix RN None lfelix@lifespan.org
Yale New Haven Hospital - New Haven, Connecticut 119.2 miles Dawn Shaddinger RN None dawn.shaddinger@yale.edu
Yale New Haven Hospital - New Haven, Connecticut 119.2 miles Dawn Shaddinger RN None dawn.shaddinger@yale.edu
Yale New Haven Hospital - New Haven, Connecticut 119.2 miles Dawn Shaddinger RN None dawn.shaddinger@yale.edu
Yale New Haven Hospital - New Haven, Connecticut 119.2 miles Dawn Shaddinger RN None dawn.shaddinger@yale.edu
Yale New Haven Hospital - New Haven, Connecticut 119.2 miles Dawn Shaddinger RN None dawn.shaddinger@yale.edu
Columbia University Medical CenterNew York Presbyterian Hospital - New York, New York 181.2 miles Kate Dalton None keb2114@cumc.columbia.edu
Columbia University Medical CenterNew York Presbyterian Hospital - New York, New York 181.2 miles Kate Dalton None keb2114@cumc.columbia.edu
Columbia University Medical CenterNew York Presbyterian Hospital - New York, New York 181.2 miles Kate Dalton None keb2114@cumc.columbia.edu
Columbia University Medical CenterNew York Presbyterian Hospital - New York, New York 181.2 miles Kate Dalton None keb2114@cumc.columbia.edu
Columbia University Medical CenterNew York Presbyterian Hospital - New York, New York 181.2 miles Kate Dalton None keb2114@cumc.columbia.edu
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Michael Gallo None michael.gallo@mountsinai.org
Lankenau Heart Center - Wynnewood, Pennsylvania 272.0 miles Ann Marie Chikowski None ChikowskiA@mlhs.org
PinnacleHealth Harrisburg Hospital - Harrisburg, Pennsylvania 333.9 miles Gretchen Meise None GMeise@PINNACLEHEALTH.org
Pinnacle Health Cardiovascular Institute - Wormleysburg, Pennsylvania 335.0 miles Gretchen Meise None GMeise@PINNACLEHEALTH.org
MedStar Cardiovascular Research Network Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles Suman Singh None Suman.Singh@medstar.net
MedStar Cardiovascular Research Network Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles Suman Singh None Suman.Singh@medstar.net
MedStar Cardiovascular Research Network Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles Suman Singh None Suman.Singh@medstar.net
MedStar Cardiovascular Research Network Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles Suman Singh None Suman.Singh@medstar.net
MedStar Cardiovascular Research Network Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles Suman Singh None Suman.Singh@medstar.net
Ascension St John Hospital and Medical Center - Detroit, Michigan 603.1 miles Rhonda Beauchemin 313-343-7536 rhonda.beauchemin@acension.org
Ascension St John Hospital and Medical Center - Detroit, Michigan 603.1 miles Rhonda Beauchemin 313-343-7536 rhonda.beauchemin@acension.org
Ascension St John Hospital and Medical Center - Detroit, Michigan 603.1 miles Rhonda Beauchemin 313-343-7536 rhonda.beauchemin@acension.org
Ascension St John Hospital and Medical Center - Detroit, Michigan 603.1 miles Rhonda Beauchemin 313-343-7536 rhonda.beauchemin@acension.org
Ascension St John Hospital and Medical Center - Detroit, Michigan 603.1 miles Rhonda Beauchemin 313-343-7536 rhonda.beauchemin@acension.org
WakeMed Heart Center - Raleigh, North Carolina 608.6 miles Rhonda Norton None Rnorton@WakeMed.org
NC Heart Vascular Research - Raleigh, North Carolina 610.5 miles Caroline Morton None cmorton@nchvresearch.com
NC Heart Vascular Research - Raleigh, North Carolina 610.5 miles Caroline Morton None cmorton@nchvresearch.com
NC Heart Vascular Research - Raleigh, North Carolina 610.5 miles Caroline Morton None cmorton@nchvresearch.com
NC Heart Vascular Research - Raleigh, North Carolina 610.5 miles Caroline Morton None cmorton@nchvresearch.com
NC Heart Vascular Research - Raleigh, North Carolina 610.5 miles Caroline Morton None cmorton@nchvresearch.com
Ascension St John Providence - Southfield, Michigan 619.5 miles Jean Kelly 248-849-3369 jean.kelly@ascension.org
Ascension St John Providence - Southfield, Michigan 619.5 miles Jean Kelly 248-849-3369 jean.kelly@ascension.org
Ascension St John Providence - Southfield, Michigan 619.5 miles Jean Kelly 248-849-3369 jean.kelly@ascension.org
Ascension St John Providence - Southfield, Michigan 619.5 miles Jean Kelly 248-849-3369 jean.kelly@ascension.org
Ascension St John Providence - Southfield, Michigan 619.5 miles Jean Kelly 248-849-3369 jean.kelly@ascension.org
Ohio Health Research Institute - Columbus, Ohio 640.9 miles Christina Belcher None christina.belcher@ohiohealth.com
Wellmont CVA Heart Institute - Kingsport, Tennessee 731.8 miles Freda Campbell 423-230-5641 freda.campbell@wellmont.org
Tennova Healthcare Turkey Creek Medical Center - Knoxville, Tennessee 830.6 miles Beth Polk RN 865-218-7535 beth.polk@tennova.com
Tennova Healthcare Turkey Creek Medical Center - Knoxville, Tennessee 830.6 miles Beth Polk RN 865-218-7535 beth.polk@tennova.com
Tennova Healthcare Turkey Creek Medical Center - Knoxville, Tennessee 830.6 miles Beth Polk RN 865-218-7535 beth.polk@tennova.com
Tennova Healthcare Turkey Creek Medical Center - Knoxville, Tennessee 830.6 miles Beth Polk RN 865-218-7535 beth.polk@tennova.com
Tennova Healthcare Turkey Creek Medical Center - Knoxville, Tennessee 830.6 miles Beth Polk RN 865-218-7535 beth.polk@tennova.com
Advocate Health and Hospitals Corporation - Oakbrook Terrace, Illinois 866.3 miles Lea Elder RN None Lea.elder@advocatehealth.org
Advocate Health and Hospitals Corporation - Oakbrook Terrace, Illinois 866.3 miles Lea Elder RN None Lea.elder@advocatehealth.org
Advocate Health and Hospitals Corporation - Oakbrook Terrace, Illinois 866.3 miles Lea Elder RN None Lea.elder@advocatehealth.org
Advocate Health and Hospitals Corporation - Oakbrook Terrace, Illinois 866.3 miles Lea Elder RN None Lea.elder@advocatehealth.org
Advocate Health and Hospitals Corporation - Oakbrook Terrace, Illinois 866.3 miles Lea Elder RN None Lea.elder@advocatehealth.org
Northeast Georgia Medical Center - Gainesville, Georgia 887.4 miles Donna Patrick None dpatrick@pulseoftomorrow.org
Prairie Education Research Cooperative - Springfield, Illinois 982.5 miles Meghan Lowrance 217-492-9100 mlowrance@prairieresearch.com
Prairie Education Research Cooperative - Springfield, Illinois 982.5 miles Meghan Lowrance 217-492-9100 mlowrance@prairieresearch.com
Prairie Education Research Cooperative - Springfield, Illinois 982.5 miles Meghan Lowrance 217-492-9100 mlowrance@prairieresearch.com
Prairie Education Research Cooperative - Springfield, Illinois 982.5 miles Meghan Lowrance 217-492-9100 mlowrance@prairieresearch.com
Prairie Education Research Cooperative - Springfield, Illinois 982.5 miles Meghan Lowrance 217-492-9100 mlowrance@prairieresearch.com
Midwest Cardiovascular Research Foundation - Davenport, Iowa 1,001.6 miles John Shammas None shammasw@mcrfmd.com
Saint Louis University - Saint Louis, Missouri 1,039.5 miles Craig Detert None cdedert@slu.edu
Tallahassee Research Institute Inc - Tallahassee, Florida 1,096.9 miles Patty Knap 850-431-5024 patty.knap@tmh.org
Tallahassee Research Institute Inc - Tallahassee, Florida 1,096.9 miles Patty Knap 850-431-5024 patty.knap@tmh.org
Tallahassee Research Institute Inc - Tallahassee, Florida 1,096.9 miles Patty Knap 850-431-5024 patty.knap@tmh.org
Tallahassee Research Institute Inc - Tallahassee, Florida 1,096.9 miles Patty Knap 850-431-5024 patty.knap@tmh.org
Tallahassee Research Institute Inc - Tallahassee, Florida 1,096.9 miles Patty Knap 850-431-5024 patty.knap@tmh.org
North Mississippi Medical Center - Tupelo, Mississippi 1,108.6 miles Marsha Jones None mrjones@nmhs.net
St Davids Heart and Vascular dba Austin Heart - Austin, Texas 1,692.4 miles Bejamin Vouk None Benjamin.Vouk@hcahealthcare.org
St Davids Heart and Vascular dba Austin Heart - Austin, Texas 1,692.4 miles Bejamin Vouk None Benjamin.Vouk@hcahealthcare.org
St Davids Heart and Vascular dba Austin Heart - Austin, Texas 1,692.4 miles Bejamin Vouk None Benjamin.Vouk@hcahealthcare.org
St Davids Heart and Vascular dba Austin Heart - Austin, Texas 1,692.4 miles Bejamin Vouk None Benjamin.Vouk@hcahealthcare.org
St Davids Heart and Vascular dba Austin Heart - Austin, Texas 1,692.4 miles Bejamin Vouk None Benjamin.Vouk@hcahealthcare.org
UCHealth Northern Colorado - Loveland, Colorado 1,759.6 miles Adam Jaskowiak 970-624-1688 adam.jaskowiak@uchealth.org
New Mexico Heart Institute - Albuquerque, New Mexico 1,970.8 miles Amy Bird None amya@nmhi.com
Abrazo Arizona Heart Hospital - Phoenix, Arizona 2,287.7 miles Patricia Ames None pames@abrazohealth.com
Stanford Hospital - Palo Alto, California 2,694.6 miles Nicholas Vesom None nvesom@stanford.edu

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