IN.PACT Global Clinical Study
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: IN.PACT Admiral™ Drug Eluting Balloon
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IN.PACT Admiral DEB IN.PACT Admiral™ Drug Eluting Balloon The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
- 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
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 - 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
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
🇦🇷Buenos Aires, Argentina
Royal Prince Alfred Hospital
🇦🇺Sydney, Australia
Clinica La Sagrada Familia
🇦🇷Bueos Aires, Argentina
Medizinische Universität Graz
🇦🇹Graz, Austria
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Onze-Lieve-Vrouwziekenuis
🇧🇪Aalst, Belgium
AZ St. Blasius
🇧🇪Dendermonde, Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan
🇧🇪Genk, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Regionaal Ziekenhuis Heilig Hart
🇧🇪Tienen, Belgium
Helsingin Seudun Yliopistollinen Keskussairaala
🇫🇮Helsinki, Finland
Centre hospitalier universitaire Sherbrooke (CHUS)
🇨🇦Sherbrooke, Canada
Toronto General Hospital
🇨🇦Toronto, Canada
Faculty Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
As-Salam International Hospital
🇪🇬Cairo, Egypt
Les Hospitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Group Hospitalier Pellegrin - CHU
🇫🇷Bordeaux Cedex, France
Herzzentrum Bad Krozingen
🇩🇪Bad Krozingen, Germany
Augusta Krankenhaus
🇩🇪Düsseldorf, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Augusta-Krankenhaus
🇩🇪Duesseldorf, Germany
Universitatsklinikum Leipzig AoR
🇩🇪Leipzig, Germany
St. Franziskus Hospital GmbH
🇩🇪Münster, Germany
Clinica Santa Maria
🇨🇴Medellin, Colombia
Clinica Medilaser Neiva
🇨🇴Neiva, Colombia
Egypt Air Hospital
🇪🇬Cairo, Egypt
Park-Krankenhaus Leipzig
🇩🇪Leipzig, Germany
Policlinico Gemelli
🇮🇹Rome, Italy
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Euromedic Medical Center
🇵🇱Katowice, Poland
Kantonspital Luzern
🇨🇭Luzern, Switzerland
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Severence Hospital
🇰🇷Seoul, Korea, Republic of
Carmel Medical Centre
🇮🇱Haifa, Israel
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
University Hospital of Patras
🇬🇷Patra, Greece
Maria Eleonora Hospital
🇮🇹Palermo, Italy
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Bacs Kiskun Megyei Korhaz
🇭🇺Kecskemét, Hungary
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Jeroen Bosch Ziekenhuis
🇳🇱's Hertogenbosch, Netherlands
Rabin Medical Center - Beilison Hospital
🇮🇱Petach Tikva, Israel
Kaunas Mecial University Clinic
🇱🇹Kaunas, Lithuania
Sint Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Changi General Hospital
🇸🇬Singapore, Singapore
Karolinska Universitetssjukhuset
🇸🇪Solna, Sweden
Northern General Hospital
🇬🇧Sheffield, United Kingdom
City Clinical Hospital named after M.E. Zhadkevich
🇷🇺Moscow, Russian Federation
Samodzielny Publiczny Szpital Kliniczny Nr 2
🇵🇱Szczecin, Poland
Hospital Santa Marta
🇵🇹Lisbon, Portugal
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
🇸🇰Kosice, Slovakia
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
🇸🇰Banská Bystrica, Slovakia
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
🇸🇰Bratislava, Slovakia
University Medical Centre Maribor
🇸🇮Maribor, Slovenia
Inselspital - Universitätsspial Bern
🇨🇭Bern, Switzerland
Hopital Cantonal HFR
🇨🇭Fribourg, Switzerland
Semmelweis University
🇭🇺Budapest, Hungary
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Landesklinikum Thermenregion Mödling
🇦🇹Mödling, Austria