RECRUITING

Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Official Title

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels with Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease

Quick Facts

Study Start:2024-09-05
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06457685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Beatriz Vendrell-Velez
CONTACT
210-414-2646
bvendrell-velez@avspulse.com
Elizabeth Galle
CONTACT
754.755.1530
liz.galle@avspulse.com

Principal Investigator

Christopher Metzger, MD
PRINCIPAL_INVESTIGATOR
Ohio Health

Study Locations (Sites)

Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52802
United States
Columbia University and New York Presbyterian Hospital (NYPH)
New York, New York, 10032
United States
OhioHealth
Columbus, Ohio, 43214
United States

Collaborators and Investigators

Sponsor: Amplitude Vascular Systems, Inc.

  • Christopher Metzger, MD, PRINCIPAL_INVESTIGATOR, Ohio Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • PAD
  • Intravascular Lithotripsy
  • Lithotripsy
  • IVL
  • PAD II
  • PAD 2
  • Pulse IVL
  • Pulsatile Lithotripsy

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease (PAD)