Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions (CRACK-IT)

Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD

This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study.

The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion.

Patients will be stratified for total occlusions.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Intravascular lithotripsy; Procedure: Standard lesion preparation

Detailed Description

All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine Steiner, Prof. Dr.; Phone Number: 18770 +49-341-97; Email: Sabine.Steiner@medizin.uni-leipzig.de
• Study Contact Backup: Name: Janine Brunotte; Phone Number: 18770 +49-341-97; Email: janine.brunotte@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University Clinic Leipzig
      • Contact: Janin Lenzer; Phone Number: 18774 +49-341-97; Email: janin.lenzer@medizin.uni-leipzig.de
      • Sub-Investigator: Dierk Scheinert, Prof. Dr.
      • Sub-Investigator: Andrej Schmidt, PD Dr.
      • Principal Investigator: Sabine Steiner, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
• Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
• Rutherford Classification 2-5
• Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
• No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
• Target lesion length is ≥ 10cm, no maximum lesion length limit
• Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
• Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
• Patency of at least one infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery
• A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)

Exclusion Criteria:

• Failure to successfully cross the target lesion
• Presence of fresh thrombus in the lesion
• Presence of aneurysm in the target vessel/s
• Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
• Prior vascular surgery of the target lesion
• Stroke or heart attack within 3 months prior to enrollment
• Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint
• Life expectancy of less than one year
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure
• Rutherford Classification of 0, 1, or 6
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Receiving immunosuppressant therapy
• Pregnant or breast-feeding females
• History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intravascular lithotripsy arm; Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification.	Procedure: Intravascular lithotripsy; Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
Other: Standard lesion preparation arm; Treatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification.	Procedure: Standard lesion preparation; Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy	Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation.	During the Procedure
Rate of primary outcome events	Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of vessel rupture	Rate of vessel rupture	During the Procedure
Need of additional stent implantation	Need of additional stent implantation	During the Procedure
Procedure Time (min)	Procedure Time (min)	During the Procedure
Fluoroscopy Duration (min)	Fluoroscopy Duration (min)	During the Procedure
Radiation dose area product	Radiation dose area product	During the Procedure
Additional need of intra-procedural pain medication	Additional need of intra-procedural pain medication	During the Procedure
Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)	Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)	During the Procedure
Rate of any dissections after lesion preparation and in the final angiogram	Rate of any dissections after lesion preparation and in the final angiogram	During the Procedure
Rate of primary patency	Rate of primary patency	6, 12, 24 and 36 months
Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion	Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion	post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention
Rate of Clinically-driven Target lesion revascularization	Rate of Clinically-driven Target lesion revascularization	30 days, 6, 12, 24, 36, 48 and 60 months
Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)	Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)	30 days, 6, 12, 24, 36, 48 and 60 months
Rate of All-cause mortality	Rate of All-cause mortality	30 days, 6, 12, 24, 36, 48 and 60 months
Ankle-brachial index (ABI)	The ABI is calculated by dividing the highest of the dorsalis pedis and posterior tibial pressures in each leg by the highest of the brachial pressures. Value less than 0.90 indicates a diagnosis of PAD.	6, 12, 24 and 36 months
Rutherford Classification	Rutherford Classification Scale from 0=Asymptomatic, 1=Mild claudication, 2=Moderate claudication, 3=Severe claudication, 4=Ischemic rest pain, 5=Minor tissue loss up to worst classification 6=Major tissue loss	6, 12, 24 and 36 months
Walking Impairment Questionnaire (WIQ)	The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks).	6, 12, 24 and 36 months
EQ-5D-5L questionnaire	The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: o problems, slight problems, moderate problems, severe problems and extreme problems.	6, 12, 24 and 36 months
EQ VAS	The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 100% 'Best imaginable health state' and 0% 'Worst imaginable health state'.	6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Sabine Steiner, Prof. Dr., University Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lithotripsy; Calcification
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Calcium Metabolism Disorders; Nutritional and Metabolic Diseases; Peripheral Arterial Disease; Calcinosis
• Other Study ID Numbers: CIP_23/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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