IN.PACT Global Clinical Study

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Registration Number: NCT01609296

Lead Sponsor: Medtronic Endovascular

Brief Summary: The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Detailed Description: Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1535

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Cohort ITT - Primary Effectiveness Endpoint	12 months	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Primary Safety Endpoint	12 months	A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Imaging Cohort ITT - Primary Effectiveness Endpoint	12 months	Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.
150mm DEB ITT Cohort - Primary Effectiveness Endpoint	12 months	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.

Secondary Outcome Measures

Name	Time	Method
Clinical Cohort ITT - MAEs	48 Months	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - TLR	48 Months	Any Target lesion revascularisation
Clinical Cohort ITT - TVR	6 Months	Any Target lesion revascularisation
Clinical Cohort ITT - Device Success	Index-procedure	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Clinical Cohort ITT - Clinical Success	prior to discharge	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Clinical Cohort ITT - Clinically-driven TLR	48 Months	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)	60 months
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.	60 months	All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement	36 Months	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	36 Months	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure	Post procedure	Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Clinical Cohort ITT - Sustained Hemodynamic Improvement	36 Months	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	36 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	36 Months	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Clinical Cohort ITT - Procedural Success	at procedure	Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion	at 12 months, or at the time of re-intervention
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion	At 12 months, or at the time of re-intervention
150mm DEB ITT Cohort - MAEs	60 months	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
150mm DEB ITT Cohort - Clinically-driven TLR	60 months	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - TLR	60 Months	Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR	60 Months	Any Target lesion revascularisation
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)	60 months
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.	60 months	All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	36 months	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	36 Months	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure	Post procedure	Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	36 Months	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)	36 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	36 Months	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
150mm DEB ITT Cohort - Device Success	Index-procedure	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
150mm DEB ITT Cohort - Procedural Success	at procedure	Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
150mm DEB ITT Cohort - Clinical Success	prior to discharge	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Clinical Cohort ITT - All-cause Mortality	60 Months	The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: 1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation 2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation 3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. 4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Clinical Cohort ITT - Clinically-driven TVR	60 Months	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Clinical Clinical Cohort ITT - Clinically-driven TVR	24 Months	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Major Target Limb Amputation	60 Months
150mm DEB ITT Cohort - All-cause Mortality	60 Months
150mm DEB ITT Cohort - Clinically-driven TVR	60 Months	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Major Target Limb Amputation	60 Months

Trial Locations

Locations (65): Fundación Favaloro
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Buenos Aires, Argentina
Clinica La Sagrada Familia
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Bueos Aires, Argentina
Royal Prince Alfred Hospital
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Sydney, Australia
Medizinische Universität Graz
🇦🇹
Graz, Austria
Landesklinikum Thermenregion Mödling
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Mödling, Austria
Onze-Lieve-Vrouwziekenuis
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Aalst, Belgium
Imelda Ziekenhuis
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Bonheiden, Belgium
AZ St. Blasius
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Dendermonde, Belgium
Universitair Ziekenhuis Antwerpen
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Edegem, Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan
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Genk, Belgium
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Fundación Favaloro
🇦🇷Buenos Aires, Argentina