Clinical trial NCT06112171: Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Calcification
Lithotripsy
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary efficacy
timeFrame: During the Procedure
measure: Rate of primary outcome events
timeFrame: 12 month
Secondary outcomes:
measure: Rate of vessel rupture
timeFrame: During the Procedure
measure: Need of additional stent implantation
timeFrame: During the Procedure
measure: Procedure Time (min)
timeFrame: During the Procedure
measure: Fluoroscopy Duration (min)
timeFrame: During the Procedure
measure: Radiation dose area product
timeFrame: During the Procedure
measure: Additional need of intra-procedural pain medication
timeFrame: During the Procedure
measure: Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)
timeFrame: During the Procedure
measure: Rate of any dissections after lesion preparation and in the final angiogram
timeFrame: During the Procedure
measure: Rate of primary patency
timeFrame: 6, 12, 24 and 36 months
measure: Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion
timeFrame: 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
measure: Rate of Clinically-driven Target lesion revascularization
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Rate of All-cause mortality
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Ankle-brachial index (ABI)
timeFrame: 6, 12, 24 and 36 months
measure: Rutherford Classification
timeFrame: 6, 12, 24 and 36 months
measure: Walking Impairment Questionnaire (WIQ)
timeFrame: 6, 12, 24 and 36 months
measure: EQ-5D-5L questionnaire
timeFrame: 6, 12, 24 and 36 months
measure: EQ VAS
timeFrame: 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Clinic Leipzig
state: Saxony
Study officials:
affiliation: University Leipzig
name: Sabine Steiner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: