Clinical trial NCT05145478: CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Official title: CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Femoral Arterial Calcification
Peripheral Arterial Disease
Claudication
Critical Limb Ischemia
Keywords: Peripheral Artery Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
name: Brown University
First posted: 2021-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population include patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia who are eligible to receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.

Brief summary: The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Detailed description: The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.

The main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. Preliminarily data will be derived for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.

Secondary objectives of the study are to document procedural success following the use of IVL in common femoral lesions, disease stage change, as well as disease-specific health status in the real-world.

Eligibility criteria: Inclusion Criteria:

* Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
* Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
* Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.

Angiographic Inclusion Criteria

* Target lesion that is located in a native, de novo common femoral artery
* Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
* Target lesion is ≥70% stenosis by investigator via visual estimate.
* Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
* Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
* Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.

Exclusion Criteria:

* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
* Cognitive impairment as documented in medical records
* Not speaking English or Spanish
* Currently a prisoner
* Pregnancy or nursing
* Estimated survival less than 12 months at the time of screening
* Prior history of CFA endarterectomy

Primary outcomes:
measure: Change in Generic Health Status
timeFrame: Baseline and 30 days
measure: Change in Generic Health Status
timeFrame: Baseline and 6 months
measure: Rate of Procedural Success
timeFrame: Immediately post procedure
Secondary outcomes:
measure: Number of Patients Free from TLR
timeFrame: Up to 12 months
measure: Number of patients with new-onset MAEs
timeFrame: Up to 12 months
measure: Rate of Periprocedural clinical success
timeFrame: During admission, before discharge up to 48 hours
measure: Change in Clinical Success
timeFrame: Baseline and 30 days
measure: Change in Clinical Success
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
measure: Change in Health Status
timeFrame: Baseline, 30 days and 6 months
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos Mena-Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kim Smolderen, PhD
role: PRINCIPAL_INVESTIGATOR
References: