Peripheral Arterial Disease
Conditions
Brief summary
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Interventions
DEVICEShockwave Medical Mini S Peripheral IVL Catheter
The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-General Inclusion Criteria 1. Age of subject is ≥ 18 years. 2. Subject is able and willing to comply with all assessments in the study. 3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. 4. Estimated life expectancy \> 1 year. 5. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s). * Angiographic Inclusion Criteria 6. One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs. 7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate. 8. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate. 9. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone. 10. 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
\- General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Major Adverse Events (MAE) | 30 days | Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular Death * Clinically Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle) |
| Primary Performance: Technical Success | Peri-Procedural | Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Angiographic Complications | Peri-Procedural | Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory. |
| IVL Technical Success (Post- Dilatation) | Peri-Procedural | Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation). |
| IVL Device Success | Peri-Procedural | Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter |
| Technical Success (Final) | Peri-Procedural | Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory |
| Major Adverse Events (MAEs) at 6-months Post Procedure | 6 Months Post-Procedure | Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle) |
| MAEs at 12-months Post Procedure | 12 Months Post-Procedure | Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle) |
| Primary Patency at 12 Months | 12 Months post-procedure | Primary patency for Above-the-Knee (ATK) lesions is defined as freedom from ≥50% restenosis as determined by DUS and freedom from CD-TLR at 12 months post-procedure. Primary patency for Below-the-Knee (BTK) lesions is defined as freedom from total occlusion (100% diameter stenosis by DUS) in all target lesions within a flow pathway and freedom from CD-TLR at 12 months post-procedure. |
Countries
Australia, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-arm Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Single-arm |
|---|---|
| Age, Continuous | 76.3 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment Australia | 13 Participants |
| Region of Enrollment New Zealand | 22 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 35 |
| other Total, other adverse events | 17 / 35 |
| serious Total, serious adverse events | 18 / 35 |
Outcome results
Primary
Primary Performance: Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
Time frame: Peri-Procedural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm | Primary Performance: Technical Success | Technical Success | 35 lesions |
| Single-arm | Primary Performance: Technical Success | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 35 lesions |
| Single-arm | Primary Performance: Technical Success | Residual Stenosis of less than or equal to 50% | 35 lesions |
p-value: <0.025Fisher Exact
Primary
Primary Safety: Major Adverse Events (MAE)
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular Death * Clinically Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm | Primary Safety: Major Adverse Events (MAE) | Major Adverse Events | 1 participants |
| Single-arm | Primary Safety: Major Adverse Events (MAE) | Cardiovascular Death | 1 participants |
| Single-arm | Primary Safety: Major Adverse Events (MAE) | Clinically-Driven Target Lesion Revascularization (CD-TLR) | 0 participants |
| Single-arm | Primary Safety: Major Adverse Events (MAE) | Unplanned Target Limb Major Amputation (Above the Ankle) | 0 participants |
p-value: <0.025Fisher Exact
Secondary
IVL Device Success
Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter
Time frame: Peri-Procedural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-arm | IVL Device Success | 41 Javelin Catheters |
Secondary
IVL Technical Success (Post- Dilatation)
Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Time frame: Peri-Procedural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm | IVL Technical Success (Post- Dilatation) | IVL Technical Success (Post-dilatation) | 30 Lesions |
| Single-arm | IVL Technical Success (Post- Dilatation) | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 34 Lesions |
| Single-arm | IVL Technical Success (Post- Dilatation) | Residual Stenosis ≤ 50% | 31 Lesions |
Secondary
MAEs at 12-months Post Procedure
Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Time frame: 12 Months Post-Procedure
Secondary
MAEs at 6-months Post Procedure
Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Time frame: 6 Months Post-Procedure
Secondary
Primary Patency at 12-Months
* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR) * Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR
Time frame: 12-Months Post Procedure
Secondary
Serious Angiographic Complications
Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory.
Time frame: Peri-Procedural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-arm | Serious Angiographic Complications | 0 Lesions |
Secondary
Technical Success (Final)
Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
Time frame: Peri-Procedural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-arm | Technical Success (Final) | IVL Technical Success (Final) | 25 lesions |
| Single-arm | Technical Success (Final) | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 35 lesions |
| Single-arm | Technical Success (Final) | Residual Stenosis ≤ 30% | 25 lesions |