Trial Outcomes & Findings for FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter (NCT NCT05858905)

NCT ID: NCT05858905

Last Updated: 2025-06-26

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2025-06-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	55
Overall Study 30 Days Post-Procedure	55
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

Baseline characteristics by cohort

Measure	JAVELIN Study Catheter n=55 Participants 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.
Age, Continuous	73.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	JAVELIN Study Catheter n=55 Participants 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.
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days Major Adverse Events	0 participants
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days Cardiovascular Death	0 participants
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days Clinically-Driven Target Lesion Revascularization (CD-TLR)	0 participants
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days Unplanned Target Limb Major Amputation (Above the Ankle)	0 participants

PRIMARY outcome

Timeframe: 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.

Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.

Outcome measures

Measure	JAVELIN Study Catheter n=63 Lesions 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.
Primary Effectiveness Endpoint - Technical Success Technical Success	62 Lesions
Primary Effectiveness Endpoint - Technical Success Freedom from Any Serious Flow-Limiting Dissection (D-F)	62 Lesions
Primary Effectiveness Endpoint - Technical Success Residual Stenosis Less Than or Equal to 50%	63 Lesions

SECONDARY outcome

Timeframe: Peri-Procedural

Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory

Outcome measures

Measure

JAVELIN Study Catheter n=63 Lesions 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.

Serious Angiographic Complications

1 Lesions

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	JAVELIN Study Catheter n=62 lesions 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.
IVL Technical Success (Post- Dilatation) IVL Technical Success (Post-dilatation)	57 lesions
IVL Technical Success (Post- Dilatation) Freedom from Any Serious Flow-Limiting Dissection (D-F)	59 lesions
IVL Technical Success (Post- Dilatation) Residual Stenosis ≤ 50%	60 lesions

SECONDARY outcome

Timeframe: Peri-Procedural

Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.

Outcome measures

Measure

JAVELIN Study Catheter n=71 Javelin Devices 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.

IVL Device Success

66 Javelin Devices

SECONDARY outcome

Timeframe: Peri-Procedural

Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory

Outcome measures

Measure	JAVELIN Study Catheter n=63 Lesions 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.
Technical Success (Final) IVL Technical Success (Final)	52 Lesions
Technical Success (Final) Residual Stenosis ≤ 30%	53 Lesions
Technical Success (Final) Freedom from Any Serious Flow-Limiting Dissection (D-F)	62 Lesions

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

JAVELIN Study Catheter

Serious events: 10 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	JAVELIN Study Catheter n=55 participants at risk 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.
Cardiac disorders Acute myocardial infarction	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Cardiac disorders Coronary artery disease	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Gastrointestinal disorders Nausea	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
General disorders Chest pain	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
General disorders Systemic inflammatory response syndrome	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Infections and infestations Infection	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Infections and infestations Osteomyelitis	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Injury, poisoning and procedural complications Vascular procedure complication	3.6% 2/55 • Number of events 2 • 30-Days post-procedure.
Musculoskeletal and connective tissue disorders Tendon Injury	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Surgical and medical procedures Foot amputation	1.8% 1/55 • Number of events 1 • 30-Days post-procedure.
Vascular disorders Peripheral arterial occlusive disease	3.6% 2/55 • Number of events 2 • 30-Days post-procedure.

Other adverse events

Measure	JAVELIN Study Catheter n=55 participants at risk 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.
Vascular disorders Peripheral arterial occlusive disease	5.5% 3/55 • Number of events 4 • 30-Days post-procedure.
Injury, poisoning and procedural complications Vascular procedure complication	30.9% 17/55 • Number of events 18 • 30-Days post-procedure.

Additional Information

Josh Popp

Shockwave Medical

Phone: 1-510-279-4262

Email: jpopp@shockwavemedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place