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

Femoral Artery Occlusion Clinical Trial

— INPACT SFA II  

Official title:

Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566461
• Other study ID #: 10031540DOC
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: May 2018

Study information

• Verified date: January 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: May 2018
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Constriction, Pathologic
• Femoral Artery Occlusion
• Femoral Artery Stenosis
• Popliteal Artery Occlusion
• Popliteal Artery Stenosis

Intervention

Device:
• Drug-Coated Balloon (DCB)
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
• PTA Balloon: Balloon Angioplasty
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Locations

Country	Name	City	State
United States	Washington Hospital	Fremont	California
United States	Kaiser Permanente Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month
Primary	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.	12 month
Secondary	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.	12 month
Secondary	All-cause Death		12 month
Secondary	Target Vessel Revascularization (TVR)		12 month
Secondary	Target Lesion Revascularization (TLR)		12 month
Secondary	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.	12 month
Secondary	Major Target Limb Amputation		12 month
Secondary	Thrombosis at the Target Lesion		12 month
Secondary	Primary Sustained Clinical Improvement	Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.	12 month
Secondary	Secondary Sustained Clinical Improvement	Freedom from target amputation and increase in Rutherford class.	12 month
Secondary	Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)		12 month
Secondary	Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)		12 month
Secondary	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'.	12 month
Secondary	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.	From baseline to 12 month
Secondary	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).	12 month
Secondary	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).	Day 1
Secondary	Procedural Success	Procedural success is defined as residual stenosis of =50% (non-stented subjects) or =30% (stented subjects) by core lab assessment.	Day 1
Secondary	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.	Day 1
Secondary	Days of Hospitalization Due to the Index Lesion	Days of hospitalization from procedure through 12 month.	12 month