Shockwave: Disruption for A Better Fit

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Shockwave Intravenous lithotripsy with a Supera stent

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sarah Melvin, MSPH; Phone Number: 2489159906; Email: sarah.melvin@cardio.com
• Study Contact Backup: Name: Deanna Benoit, LPN; Phone Number: 9858735613; Email: deanna.benoit@cardio.com

Study Locations

• United States
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Recruiting
      • Cardiovascular Institute of the South
      • Principal Investigator: Craig Walker, MD
      • Contact: Sarah Melvin, MSPH; Email: sarah.melvin@cardio.com
      • Contact: Deanna Benoit, LPN; Email: deanna.benoit@cardio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	determining effectiveness of the procedure will be defined as final residual stenosis of <30% post-stent placement, as measured by IVUS.	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.	up to 30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
improved quality of life	relief of symptoms related to intermittent claudication (IC) as reported by the patient during follow up visit	1 year

Collaborators and Investigators

• Sponsor: Cardiovascular Institute of the South Clinical Research Corporation
• Collaborators: Shockwave Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): June 7, 2022
• Study Completion (Anticipated): December 7, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CardiovascularIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be kept within CIS and not shared with anyone outside of the organization

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No