Peripheral Arterial DiseaseNCT05147363
Shockwave: Disruption for A Better Fit
An observational study of Peripheral Arterial Disease, run by Cardiovascular Institute of the South Clinical Research Corporation at 1 site in United States.
Trial summary
Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Shockwave Intravenous lithotripsy with a Supera stent
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 22 Jul 2022
- 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
- Adult, Older adult
Study population: 50 consented adults 18 years of age or older, identified to have de novo, severely calcified femoral popliteal arteries requiring revascularization
Who may be able to join
- age ≥ 18 years
- Treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by IVUS.
- Lesion lengths up to 140 mm.
- Planned follow-up within the health clinic.
Who cannot join
- Calcified femoral popliteal arteries that show <70% stenosis by angiography.
- Calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon.
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension).
- Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD).
- Currently receiving treatment in an investigational device or drug study or anticipate participating in an investigational device or drug study for the duration of this study.
- Anticipated life expectancy less than 6 months.
- Lack of phone or email for contact.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Institute of the South
Houma, Louisiana, 70360
About this study
Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Therefore, the use of IVL prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. The investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of Major Adverse Cardiac Event including death or any amputation of the index limb within 30 days of the procedure.
Read the detailed description
The purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a Supera stent for the treatment of calcified femoral popliteal arteries. The use of IVL and Supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. Following enrollment and index procedure, the subject will be followed prospectively for one year.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Shockwave Intravenous lithotripsy with a Supera stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave Intravenous lithotripsy with a Supera stentDevice
Pre-dilation with the option of using a 2-3mm balloon to cross a lesion for lithotripsy with the shockwave device followed by placement of supera stent.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
determining effectiveness of the procedure will be defined as final residual stenosis of <30% post-stent placement, as measured by IVUS.
Measured: immediately after the intervention
Major adverse cardiac events
a composite of Major Adverse Cardiac events (MACE) including death and any amputation of the index limb within 30 days. Study success will be defined as those patients who meet both the effectiveness and safety objectives.
Measured: up to 30 days
Secondary outcomes (4)
increase in minimum lumen area
to observe an increase in the minimum lumen area following IVL treatment measured in mm2 by intravenous ultrasound
Measured: immediately following intervention
Patency of index vessel
primary patency rate of ≥80% measured by extravascular ultrasound
Measured: up to 6 months
Extended patency of index vessel
long term patency of index vessel of ≥80% measured by extravascular ultrasound
Measured: 1 year
improved ankle-brachial index
a change in ankle-brachial index measured by the ankle pressure in mmHg divided by the brachial pressure in mmHg
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start7 Dec 2020
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Why it stopped: Study device unable to be provided with grant
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Institute of the South Clinical Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Craig Walker, MD, Principal investigator, Cardiovascular Institute of the South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147363
- Sponsor's protocol ID
- CardiovascularIS
- Status last verified
- May 2026
- First submitted
- 15 Oct 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be kept within CIS and not shared with anyone outside of the organization
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave: Disruption for A Better Fit
- ClinicalTrials.gov ID
- NCT05147363
- Acronym / sponsor ID
- CardiovascularIS
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study device unable to be provided with grant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardiovascular Institute of the South Clinical Research CorporationUniversity, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 7 Dec 2021 (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.
Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Therefore, the use of IVL prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. The investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of Major Adverse Cardiac Event including death or any amputation of the index limb within 30 days of the procedure.
Detailed description
The purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a Supera stent for the treatment of calcified femoral popliteal arteries. The use of IVL and Supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. Following enrollment and index procedure, the subject will be followed prospectively for one year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 50 consented adults 18 years of age or older, identified to have de novo, severely calcified femoral popliteal arteries requiring revascularization
Key inclusion criteria (4 listed)
- age ≥ 18 years
- Treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by IVUS.
- Lesion lengths up to 140 mm.
- Planned follow-up within the health clinic.
Key exclusion criteria (8 listed)
- Calcified femoral popliteal arteries that show <70% stenosis by angiography.
- Calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon.
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension).
- Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave Intravenous lithotripsy with a Supera stentPre-dilation with the option of using a 2-3mm balloon to cross a lesion for lithotripsy with the shockwave device followed by placement of supera stent. | Device | – |
Primary outcome
Effectiveness
Time frame: immediately after the intervention
determining effectiveness of the procedure will be defined as final residual stenosis of <30% post-stent placement, as measured by IVUS.
Major adverse cardiac events
Time frame: up to 30 days
a composite of Major Adverse Cardiac events (MACE) including death and any amputation of the index limb within 30 days. Study success will be defined as those patients who meet both the effectiveness and safety objectives.
4 secondary outcomes
increase in minimum lumen area
Time frame: immediately following intervention
Patency of index vessel
Time frame: up to 6 months
Extended patency of index vessel
Time frame: 1 year
improved ankle-brachial index
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will be kept within CIS and not shared with anyone outside of the organization
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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.
Craig Walker, MD principal investigator
Cardiovascular Institute of the South
1 site in 1 country: 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 Cardiovascular Institute of the South Clinical Research Corporation at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Effectiveness (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. 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 27 May 2026.