Peripheral Arterial Disease
Conditions
Keywords
Intravascular Lithotripsy
Brief summary
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Interventions
The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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. General
Exclusion criteria
1. Rutherford Clinical Category 0, 1 and 6 (target limb). 2. History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment. 3. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 4. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 5. Subject has known allergy to urethane, nylon, or silicone. 6. Myocardial infarction within 60 days prior to enrollment. 7. History of stroke within 60 days prior to enrollment. 8. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. 9. Subject is pregnant or nursing. 10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 11. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. 12. Covid-19 diagnosis within 30 days. 13. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure. 14. Planned major amputation of target limb. 15. Acute limb ischemia. 16. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). 17. Subject already enrolled into this study. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days | 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 Effectiveness Endpoint - Technical Success | Peri-Procedural, immediately after all therapy of the target lesion was completed. | Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 | * 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 |
| 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) |
| IVL Technical Success (Post- Dilatation) | Peri-Procedural | Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JAVELIN Study Catheter The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | JAVELIN Study Catheter |
|---|---|
| Age, Continuous | 73.4 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 48 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 20 / 55 |
| serious Total, serious adverse events | 10 / 55 |
Outcome results
Primary
Primary Effectiveness Endpoint - Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.
Time frame: Peri-Procedural, immediately after all therapy of the target lesion was completed.
Population: Analysis was performed at the lesion level, where 55 subjects had 63 target lesions with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JAVELIN Study Catheter | Primary Effectiveness Endpoint - Technical Success | Technical Success | 62 Lesions |
| JAVELIN Study Catheter | Primary Effectiveness Endpoint - Technical Success | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 62 Lesions |
| JAVELIN Study Catheter | Primary Effectiveness Endpoint - Technical Success | Residual Stenosis Less Than or Equal to 50% | 63 Lesions |
Primary
Primary Safety Endpoint - Major Adverse Events (MAE) at 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)
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JAVELIN Study Catheter | Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days | Major Adverse Events | 0 participants |
| JAVELIN Study Catheter | Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days | Cardiovascular Death | 0 participants |
| JAVELIN Study Catheter | Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days | Clinically-Driven Target Lesion Revascularization (CD-TLR) | 0 participants |
| JAVELIN Study Catheter | Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days | Unplanned Target Limb Major Amputation (Above the Ankle) | 0 participants |
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) |
|---|---|---|
| JAVELIN Study Catheter | IVL Device Success | 66 Javelin Devices |
Secondary
IVL Technical Success (Post- Dilatation)
Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Time frame: Peri-Procedural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JAVELIN Study Catheter | IVL Technical Success (Post- Dilatation) | IVL Technical Success (Post-dilatation) | 57 lesions |
| JAVELIN Study Catheter | IVL Technical Success (Post- Dilatation) | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 59 lesions |
| JAVELIN Study Catheter | IVL Technical Success (Post- Dilatation) | Residual Stenosis ≤ 50% | 60 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 (COUNT_OF_UNITS) |
|---|---|---|
| JAVELIN Study Catheter | Serious Angiographic Complications | 1 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) |
|---|---|---|---|
| JAVELIN Study Catheter | Technical Success (Final) | IVL Technical Success (Final) | 52 Lesions |
| JAVELIN Study Catheter | Technical Success (Final) | Freedom from Any Serious Flow-Limiting Dissection (D-F) | 62 Lesions |
| JAVELIN Study Catheter | Technical Success (Final) | Residual Stenosis ≤ 30% | 53 Lesions |