- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01175850
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease (INPACT SFA I)
Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:
- the need for re-dilatation of the previously treated vessel segment
- an ultrasound examination The safety of the IN.PACT Admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pettenkoferstr
-
Rosenheim, Pettenkoferstr, Germany, 83022
- Klinikum Rosenheim Institut für Diagnostische und Interventionelle Radiologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion Criteria:
- Age ≥18 years and ≤85 years
- Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form
Angiographic Inclusion Criteria:
- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)
General Exclusion Criteria:
- Patient unwilling or unlikely to comply with follow-up schedule
- Stroke or STEMI within 3 months prior enrolment
Angiographic Exclusion Criteria:
- Acute or sub-acute thrombus in the target vessel
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug-Coated Balloon (DCB)
IN.PACT Admiral: Balloon Angioplasty
|
balloon dilatation and provisional stenting with IN.PACT DCB
|
Active Comparator: Standard PTA
Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty
|
balloon dilatation and provisional stenting with standard non-coated PTA balloon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Patency
Time Frame: 12 Month
|
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.
|
12 Month
|
Primary Safety Composite
Time Frame: 12 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Death
Time Frame: 12 month
|
12 month
|
|
Major Adverse Events (MAE) Composite
Time Frame: 12 month
|
Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site
|
12 month
|
Target Vessel Revascularization (TVR)
Time Frame: 12 month
|
12 month
|
|
Target Lesion Revascularization (TLR)
Time Frame: 12 month
|
12 month
|
|
Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)
Time Frame: 12 month
|
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
|
Major Target Limb Amputation
Time Frame: 12 month
|
12 month
|
|
Thrombosis at the Target Lesion
Time Frame: 12 month
|
12 month
|
|
Primary Sustained Clinical Improvement
Time Frame: 12 month
|
Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.
Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.
|
12 month
|
Secondary Sustained Clinical Improvement
Time Frame: 12 month
|
Freedom from target limb amputation and increase in Rutherford class.
|
12 month
|
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).
Time Frame: 12 month
|
Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.
|
12 month
|
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).
Time Frame: 12 month
|
12 month
|
|
Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12
Time Frame: Baseline to 12 month
|
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'. |
Baseline to 12 month
|
Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months
Time Frame: 12 month
|
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
|
Device Success
Time Frame: Day 1
|
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
|
Procedural Success
Time Frame: Day 1
|
Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)
|
Day 1
|
Clinical Success
Time Frame: Day 1
|
Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.
|
Day 1
|
Days of Hospitalization Due to the Index Lesion
Time Frame: 12 month
|
Days of hospitalization from procedure through 12 month.
|
12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gunnar Tepe, Prof Dr. Med, Klinikum Rosenheim
Publications and helpful links
General Publications
- Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
- Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
- Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019 Jun;12(6):e007702. doi: 10.1161/CIRCINTERVENTIONS.118.007702. Epub 2019 Jun 14.
- Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
- Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, Metzger C, Micari A, Sachar R, Jaff MR, Wang H, Hasenbank MS, Krishnan P; IN.PACT SFA Trial Investigators. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS.117.005891.
- Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015 Feb 3;131(5):495-502. doi: 10.1161/CIRCULATIONAHA.114.011004. Epub 2014 Dec 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P990
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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