Peripheral Arterial DiseaseCRACK-ITNCT06112171
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
A study testing Intravascular lithotripsy and Standard lesion preparation in people with Peripheral Arterial Disease, run by University of Leipzig at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Intravascular lithotripsy and Standard lesion preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 13 Feb 2024to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Leipzig
Leipzig, Saxony, 04103
Janin Lenzer, +49-341-97 ext. 18774, janin.lenzer@medizin.uni-leipzig.de
Dierk Scheinert, Prof. Dr.
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Intravascular lithotripsy, Standard lesion preparation
- Keywords
- Calcification, Lithotripsy
- Medical subject headings
- Peripheral Arterial Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsyProcedure or surgery
Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
Standard lesion preparationProcedure or surgery
Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Intravascular lithotripsy arm | Other | Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification. Receives: Procedure: Intravascular lithotripsy |
| Standard lesion preparation arm | Other | Treatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification. Receives: Procedure: Standard lesion preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 month
Secondary outcomes (18)
Rate of vessel rupture
Rate of vessel rupture
Measured: During the Procedure
Need of additional stent implantation
Need of additional stent implantation
Measured: During the Procedure
Procedure Time (min)
Procedure Time (min)
Measured: During the Procedure
Fluoroscopy Duration (min)
Fluoroscopy Duration (min)
Measured: During the Procedure
Radiation dose area product
Radiation dose area product
Measured: During the Procedure
Additional need of intra-procedural pain medication
Additional need of intra-procedural pain medication
Measured: 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)
Measured: 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
Measured: During the Procedure
Rate of primary patency
Rate of primary patency
Measured: 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
Measured: 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
Measured: 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)
Measured: 30 days, 6, 12, 24, 36, 48 and 60 months
Rate of All-cause mortality
Rate of All-cause mortality
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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'.
Measured: 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start13 Feb 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Steiner, Prof. Dr., Principal investigator, University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112171
- Sponsor's protocol ID
- CIP_23/001
- Acronym
- CRACK-IT
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06112171
- Acronym / sponsor ID
- CRACK-IT / CIP_23/001
- Conditions
- Peripheral Arterial Disease
- Keywords
- Calcification, Lithotripsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular lithotripsy arm | Other | Procedure: Intravascular lithotripsyTreatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification. |
| Standard lesion preparation arm | Other | Procedure: Standard lesion preparationTreatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular lithotripsyLesion preparation with Shockwave Medical Peripheral Lithotripsy System | Procedure or surgery | Intravascular lithotripsy arm |
| Standard lesion preparationLesion preparation with Standard and/or High-Pressure Balloon Angioplasty | Procedure or surgery | Standard lesion preparation arm |
Primary outcome
Primary efficacy
Time frame: During the Procedure
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.
Rate of primary outcome events
Time frame: 12 month
Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization
18 secondary outcomes
Rate of vessel rupture
Time frame: During the Procedure
Need of additional stent implantation
Time frame: During the Procedure
Procedure Time (min)
Time frame: During the Procedure
Fluoroscopy Duration (min)
Time frame: During the Procedure
Radiation dose area product
Time frame: During the Procedure
Additional need of intra-procedural pain medication
Time frame: During the Procedure
Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)
Time frame: During the Procedure
Rate of any dissections after lesion preparation and in the final angiogram
Time frame: During the Procedure
Rate of primary patency
Time frame: 6, 12, 24 and 36 months
Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion
Time frame: 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
Time frame: 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)
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Rate of All-cause mortality
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Ankle-brachial index (ABI)
Time frame: 6, 12, 24 and 36 months
Rutherford Classification
Time frame: 6, 12, 24 and 36 months
Walking Impairment Questionnaire (WIQ)
Time frame: 6, 12, 24 and 36 months
EQ-5D-5L questionnaire
Time frame: 6, 12, 24 and 36 months
EQ VAS
Time frame: 6, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabine Steiner, Prof. Dr. principal investigator
University Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy and Standard lesion preparation in people with Peripheral Arterial Disease, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Steiner, Prof. Dr. (+49-341-97 ext. 18770, Sabine.Steiner@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy (time frame: During the Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.