Peripheral Arterial DiseasePAD III OSNCT05881421
DISRUPT PAD III Observational Study
An observational study of Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 30 sites in 3 countries.
Trial summary
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 1,373 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 16 Nov 2017to 10 Jun 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the study sites with known PAD requiring an interventional procedure were evaluated for eligibility and participation in the study. If a patient met the baseline pre-procedure screening of inclusion and none of the exclusion criteria for the protocol version current at time of screening, and was willing to participate in the study, written consent was obtained. No study-specific requirements were performed prior to obtaining informed consent.
Who may be able to join
- Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:
- Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
- Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
- Age of subject is > 18.
- Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- 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 if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
Who cannot join
- Subjects that met ANY of the following exclusion criteria were not included in this clinical study:
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
- Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States26 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
St. David's Heart and Vascular (Austin Heart)
Austin, Texas, 78756
St. John Clinic
Bartlesville, Oklahoma, 74006
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Charleston Area Medical Center
Charleston, West Virginia, 25304
Ohio Health Research Institute
Columbus, Ohio, 43214
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
Baylor Clinic McNair Campus
Houston, Texas, 77030
St. Luke's Cardiovascular Consultants
Kansas City, Missouri, 64111
UCHealth Northern Colorado
Loveland, Colorado, 80538
Baptist Medical Center
Memphis, Tennessee, 38120
Mount Sinai West
New York, New York, 10019
Columbia University Medical Center
New York, New York, 10032
Stanford Hospital
Palo Alto, California, 94304
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341
Providence Heart & Vascular Institute
Portland, Oregon, 97225
The Miriam Hospital
Providence, Rhode Island, 02906
NC Heart & Vascular Research, LLC
Raleigh, North Carolina, 27607
Tallahassee Research Institute Inc.
Tallahassee, Florida, 32308
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany3 sites
Evangelisches Krankenhaus Mulheim an der Ruhr
Mülheim
St. Franziskus Hospital
Münster
RoMed Klinikum Rosenheim
Rosenheim
About this study
Official title: Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions.
Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Intravascular Lithotripsy
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success - Primary Effectiveness Endpoint
Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ grade D) by angiographic core lab. In the primary analysis, Procedural Success was assessed on a per-subject basis; for subjects with multiple IVL-treated lesions, Procedural Success was achieved if all lesions met criteria.
Measured: Peri-procedural, approximately 2 hours
Secondary outcomes (1)
Procedural Success - Secondary Effectiveness Endpoint
As secondary analyses, Procedural Success was also assessed on a per-lesion basis, as well as using a <50% residual stenosis threshold.
Measured: Peri-procedural, approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start16 Nov 2017
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,373 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881421
- Sponsor's protocol ID
- CP 60892 OS
- Acronym
- PAD III OS
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
- ClinicalTrials.gov ID
- NCT05881421
- Acronym / sponsor ID
- PAD III OS / CP 60892 OS
- Conditions
- Peripheral Arterial Disease
- Keywords
- Intravascular Lithotripsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,373 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions.
Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the study sites with known PAD requiring an interventional procedure were evaluated for eligibility and participation in the study. If a patient met the baseline pre-procedure screening of inclusion and none of the exclusion criteria for the protocol version current at time of screening, and was willing to participate in the study, written consent was obtained. No study-specific requirements were performed prior to obtaining informed consent.
Key inclusion criteria (6 listed)
- Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:
- Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
- Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
- Age of subject is > 18.
- Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Key exclusion criteria (3 listed)
- Subjects that met ANY of the following exclusion criteria were not included in this clinical study:
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
- Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural Success - Primary Effectiveness Endpoint
Time frame: Peri-procedural, approximately 2 hours
Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ grade D) by angiographic core lab. In the primary analysis, Procedural Success was assessed on a per-subject basis; for subjects with multiple IVL-treated lesions, Procedural Success was achieved if all lesions met criteria.
1 secondary outcome
Procedural Success - Secondary Effectiveness Endpoint
Time frame: Peri-procedural, approximately 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Related trials for Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success - Primary Effectiveness Endpoint (time frame: Peri-procedural, approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.