Shockwave: Disruption for A Better Fit

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05147363
• Lead Sponsor: Cardiovascular Institute of the South Clinical Research Corporation

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.

Study Timeline

• Study Start: 2020-12-07
• Study First Submitted: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-06-07
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	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.
Effectiveness	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.

Secondary Outcome Measures

Name	Time	Method
increase in minimum lumen area	immediately following intervention	the change in minimum lumen area following IVL treatment measured in mm2 by intravenous ultrasound
Patency of index vessel	up to 6 months	primary patency rate of ≥80% measured by extravascular ultrasound
improved ankle-brachial index	1 year	an increase in ankle-brachial index measured by the ankle pressure in mmHg divided by the brachial pressure in mmHg
Extended patency of index vessel	1 year	long term patency of index vessel of ≥80% measured by extravascular ultrasound

Trial Locations

Locations (1)

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States