Vascular DiseasesNCT04600934
Shockwave Assisted Large Bore Access
A study testing Shockwave and Plain old balloon angioplasty in people with Vascular Diseases, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Shockwave and Plain old balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 28 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Indicated for planned procedure requiring large bore (>12 French sheath) access
- Mental capacity to provide informed consent
- Iliac access vessel demonstrates >50% circumferential calcium
- Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
- Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
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- Preoperative CT angiogram, </= 5mm slices
- Preoperative ABI/TP
- Unsuccessful delivery of large bore sheath without adjunctive intervention
- o Definition of unsuccessful = operator assessment of the following
- Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
- Adverse forward pressure application by operator
- Failure of device to track with external pressure applied to abdomen
- Patient intolerance of advancement (pain response) in awake patient
Who cannot join
- Contraindicated for antiplatelet therapy (aspirin or plavix)
- Planned iliofemoral surgical reconstruction in next 30 days
- Prior common or external iliac artery stent placement
- Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
- Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
- Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
- Inability to traverse iliac segment with wire
- Emergent procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.
The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.
- Conditions
- Vascular Diseases
- Being tested
- Shockwave, Plain old balloon angioplasty
- Keywords
- Vascular Surgery
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShockwaveDevice
Shockwave Medical, Inc. Peripheral Lithoplasty® System
Plain old balloon angioplastyDevice
POBA
| Study group | Role | What they receive |
|---|---|---|
| Standard POBA (plain old balloon angioplasty) | Active comparator | The first 50 patients will be pre-treated with standard POBA Receives: Device: Plain old balloon angioplasty |
| Shockwave | Experimental | The second 50 patients will be treated primarily with Shockwave Receives: Device: Shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful advancement of planned large bore access device
Technical success-defined as successful advancement of planned large bore access device without use of additional adjuncts (stenting, repeat shockwave treatment, high pressure balloon, alternative access pathway)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start3 Oct 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Principal investigator, Mathew Wooster, Medical University of South Carolina
- Investigators
- Mathew Wooster, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600934
- Sponsor's protocol ID
- 00103170
- Status last verified
- Sep 2023
- First submitted
- 19 Oct 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
- ClinicalTrials.gov ID
- NCT04600934
- Acronym / sponsor ID
- 00103170
- Conditions
- Vascular Diseases
- Keywords
- Vascular Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 23 Oct 2020 (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.
Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.
The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard POBA (plain old balloon angioplasty) | Active comparator | Device: Plain old balloon angioplastyThe first 50 patients will be pre-treated with standard POBA |
| Shockwave | Experimental | Device: ShockwaveThe second 50 patients will be treated primarily with Shockwave |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age >18 years
- Indicated for planned procedure requiring large bore (>12 French sheath) access
- Mental capacity to provide informed consent
- Iliac access vessel demonstrates >50% circumferential calcium
- Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
Key exclusion criteria (8 listed)
- Contraindicated for antiplatelet therapy (aspirin or plavix)
- Planned iliofemoral surgical reconstruction in next 30 days
- Prior common or external iliac artery stent placement
- Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
- Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
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 |
|---|---|---|
| ShockwaveShockwave Medical, Inc. Peripheral Lithoplasty® System | Device | Shockwave |
| Plain old balloon angioplastyPOBA | Device | Standard POBA (plain old balloon angioplasty) |
Primary outcome
Successful advancement of planned large bore access device
Time frame: Day 1
Technical success-defined as successful advancement of planned large bore access device without use of additional adjuncts (stenting, repeat shockwave treatment, high pressure balloon, alternative access pathway)
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 3 Sep 2024.
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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.
Mathew Wooster, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave and Plain old balloon angioplasty in people with Vascular Diseases, run by Medical University of South Carolina 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 14 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 3 Sep 2024. 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?
Successful advancement of planned large bore access device (time frame: Day 1). 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 3 Sep 2024.