Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug961	ESPRIT™ BTK Device Wiki	1.00

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D007511	Ischemia NIH	0.45

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: It includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

Measure: Composite of Limb Salvage and Primary Patency at 6 Months

Time: At 6 months

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Description: MALE includes above ankle amputation in index limb, major re-intervention at 6 months and POD includes perioperative (30 day) mortality.

Measure: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)

Time: At 30 days (for POD) and 6 months (for MALE)

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Secondary Outcomes

Description: Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus ESPRIT BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.

Measure: Number of Participants with Acute Procedure Success

Time: Immediately after the procedure

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Description: Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

Measure: Number of Participants with Device Success

Time: During the procedure

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Description: Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.

Measure: Number of Participants with Technical Success

Time: During the procedure

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Description: Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.

Measure: Number of Participants with Clinical Success

Time: Within 2 days after the index procedure or at hospital discharge

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Description: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).

Measure: Number of Participants with Angiographic acute gain (in-segment)

Time: Immediately after the procedure

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Description: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for ESPRIT arm only

Measure: Number of Participants with Angiographic acute gain (in-device)

Time: Immediately after the procedure

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Description: Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

Measure: Composite of Limb Salvage and Primary Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: MALE includes above ankle amputation in index limb, major re-interventions at 1 month, 3 months, 6 months, 1 year and annually through 5 years, and POD includes perioperative (30 day) mortality.

Measure: Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Freedom From Above Ankle Amputation

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Freedom from re-narrowing of the artery following the alleviation of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by angiography.

Measure: Freedom From Restenosis

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Number of Amputation-free Survival

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: All-cause Death composed of cardiac death, vascular death and non-cardiovascular death

Measure: Number of All-cause Death

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms. Acute thrombosis: 0 - 24 hours post study procedure Subacute thrombosis: > 24 hours - 30 days post study procedure Late thrombosis: 31 days - 1 year post-procedure Very late thrombosis: > 1 year post-procedure Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.

Measure: Number of Participants with Arterial Thrombosis

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Major Limb Re-interventions includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization

Measure: Number of Participants with Major Re-intervention on index limb

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis

Measure: Primary Assisted Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion

Measure: Secondary Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography

Measure: Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Measure: Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

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Description: Wound assessment will be performed to determine whether the wound is improving (i.e. healing), not changing, or worsening.

Measure: Target Wound Assessment for Healing

Time: At 14 days, 30 days, 42 days and 90 days

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Description: Wound Assessment for Infection will be performed to determine the clinical indication of the presence or absence of infection.

Measure: Target Wound Assessment for Infection

Time: At 14 days, 30 days, 42 days and 90 days

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Description: The Rutherford Becker scale is a classification system for claudication and limb ischemia. Categories and Clinical Description: Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).

Measure: Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb

Time: At baseline,1 month, 3 months, 6 months, 1 year and annually through 5 years

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