Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

Peripheral Arterial Disease Clinical Trial

— CRACK-IT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112171
• Other study ID #: CIP_23/001
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: September 2023
• Source: University of Leipzig
• Contact: Sabine Steiner, Prof. Dr.
• Phone: +49-341-97
• Email: Sabine.Steiner[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2030
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Intravascular lithotripsy
Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
• Standard lesion preparation
Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Locations

Country	Name	City	State
Germany	University Clinic Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of vessel rupture	Rate of vessel rupture	During the Procedure
Secondary	Need of additional stent implantation	Need of additional stent implantation	During the Procedure
Secondary	Procedure Time (min)	Procedure Time (min)	During the Procedure
Secondary	Fluoroscopy Duration (min)	Fluoroscopy Duration (min)	During the Procedure
Secondary	Radiation dose area product	Radiation dose area product	During the Procedure
Secondary	Additional need of intra-procedural pain medication	Additional need of intra-procedural pain medication	During the Procedure
Secondary	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
Secondary	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
Secondary	Rate of primary patency	Rate of primary patency	6, 12, 24 and 36 months
Secondary	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
Secondary	Rate of Clinically-driven Target lesion revascularization	Rate of Clinically-driven Target lesion revascularization	30 days, 6, 12, 24, 36, 48 and 60 months
Secondary	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
Secondary	Rate of All-cause mortality	Rate of All-cause mortality	30 days, 6, 12, 24, 36, 48 and 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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