MedDataX Logo

Shockwave: Disruption for A Better Fit

NCT ID: NCT05147363

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-07

Study Completion Date

2022-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Shockwave Intravenous lithotripsy with a Supera stent

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role collaborator

Cardiovascular Institute of the South Clinical Research Corporation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Institute of the South

Houma, Louisiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Melvin, MSPH

Role: CONTACT

Phone: 2489159906

Email: [email protected]

Deanna Benoit, LPN

Role: CONTACT

Phone: 9858735613

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah Melvin, MSPH

Role: primary

Deanna Benoit, LPN

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CardiovascularIS

Identifier Type: -

Identifier Source: org_study_id