IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)

Medtronic Endovascular331 enrolled

Overview

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

331

Conditions

Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: \> or equal to 18 years and \< or equal to 85 years * Documented ischemia with Rutherford classification 2, 3, or 4 * Target lesion in the SFA and/or PPA * Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria: 1. 70 - 99% occlusion by visual estimate with lesion length \> or equal to 4 cm and \< or equal to 18 cm 2. 100% occlusion by visual estimate with lesion length \< or equal to 10 cm 3. Combination lesions must have a total lesion length of \> or equal to 4 cm and \< or equal to 18 cm with an occluded segment that is \< or equal to 10 cm (by visual estimate) * Target vessel diameter \> or equal to 4 mm and \< or equal to 7 mm * Angiographic evidence of adequate distal run-off to the ankle * Able to walk without assistive devices Exclusion Criteria: * Stroke or heart attack within 3 months prior to enrollment * Enrolled in another investigational drug, device or biologic study * Any surgical procedure or intervention performed within 30 days prior to or post index procedure * SFA or PPA disease in the opposite leg that requires treatment at the index procedure * Failure to successfully cross the target lesion * Angiographic evidence of severe calcification * Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices) * Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure * Chronic kidney disease

Outcomes

Primary Outcomes

Primary Patency

Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.

Time frame: 12 month

Primary Safety Composite

Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.

Time frame: 12 month

Secondary Outcomes

Major Adverse Event (MAE) Composite

Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.

Time frame: 12 month

All-cause Death

Time frame: 12 month

Target Vessel Revascularization (TVR)

Time frame: 12 month

Target Lesion Revascularization (TLR)

Time frame: 12 month

Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)

Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post procedure baseline.

Time frame: 12 month

Major Target Limb Amputation

Time frame: 12 month

Thrombosis at the Target Lesion

Time frame: 12 month

Primary Sustained Clinical Improvement

Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.

Time frame: 12 month

Secondary Sustained Clinical Improvement

Freedom from target amputation and increase in Rutherford class.

Time frame: 12 month

Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)

Time frame: 12 month

Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)

Time frame: 12 month

Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)

Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used. EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.

Time frame: 12 month

Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)

Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.

Time frame: From baseline to 12 month

Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)

Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication. Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).

Time frame: 12 month

Device Success

Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).

Time frame: Day 1

Procedural Success

Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.

Time frame: Day 1

Clinical Success

Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.

Time frame: Day 1

Days of Hospitalization Due to the Index Lesion

Days of hospitalization from procedure through 12 month.

Time frame: 12 month

IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes