Shockwave: Disruption for A Better Fit

NCT05147363 | Unknown DMC

• 1 other identifier: CardiovascularIS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• increase in minimum lumen area

  immediately following intervention

• Patency of index vessel

  up to 6 months

• Extended patency of index vessel

  1 year

• improved ankle-brachial index

  1 year

Other Outcomes (1)

• improved quality of life

  1 year

Interventions

Shockwave Intravenous lithotripsy with a Supera stent DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiovascular Institute of the South Clinical Research Corporation: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Sarah Melvin, MSPH

CONTACT

2489159906; sarah.melvin@cardio.com

Deanna Benoit, LPN

CONTACT

9858735613; deanna.benoit@cardio.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: December 7, 2021
• Study Start: December 7, 2020
• Primary Completion: June 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)