Clinical trial NCT05147363: Shockwave: Disruption for A Better Fit
Official title: Shockwave: Disruption for A Better Fit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: Cardiovascular Institute of the South Clinical Research Corporation
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
First posted: 2021-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 consented adults 18 years of age or older, identified to have de novo, severely calcified femoral popliteal arteries requiring revascularization

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness
timeFrame: immediately after the intervention
measure: Major adverse cardiac events
timeFrame: up to 30 days
Secondary outcomes:
measure: increase in minimum lumen area
timeFrame: immediately following intervention
measure: Patency of index vessel
timeFrame: up to 6 months
measure: Extended patency of index vessel
timeFrame: 1 year
measure: improved ankle-brachial index
timeFrame: 1 year
Other outcomes:
measure: improved quality of life
timeFrame: 1 year
Locations:
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
Study officials:
References: