IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
Study Details
Study Description
Brief Summary
To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: drug-eluting balloon IN.PACT 014 product is indicated for PTA in patients with obstructive disease of peripheral arteries with paclitaxel drug - elution. |
Device: DCB
Drug Coated Balloon
|
| Active Comparator: Standard angioplasty balloon standard PTA balloon |
Device: PTA
Percutaneous Transluminal Angioplasty
|
Outcome Measures
Primary Outcome Measures
- Efficacy: Late lumen loss (LLL) at 9 months [9 Months]
Late lumen loss (LLL) at 9 months
Secondary Outcome Measures
- Composite Safety Endpoint [30 days and 9 Months]
A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure.
- Major Adverse Event (MAE) rate [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
- Status of wound healing [at 30 days, 3, 6, 9, 12, 24 and 36 months]
completely healed - improvement - unchanged - worsened
- Rate of thrombosis at the target lesion [through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months]
Rate of thrombosis at the target lesion
- Device success [at the time of procedure]
is defined as successful drug delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
- Clinical success [up to discharge visit]
is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR))
- Functional flow assessment [at 3, 6, 9, 12, 24 and 36 months]
is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound
- Death of any cause and cardiovascular-related deaths [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
Death of any cause and cardiovascular-related deaths
- Major Target Limb Amputation rate [through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months]
Major Target Limb Amputation rate
- Mechanically-driven Target Lesion Revascularization (TLR) rate [through 37 days]
Mechanically-driven Target Lesion Revascularization (TLR) rate
- Target Lesion Revascularization (TLR) rate [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
Target Lesion Revascularization (TLR) rate
- Clinically-driven Target Lesion Revascularization (CD-TLR) rate [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
Clinically-driven Target Lesion Revascularization (CD-TLR) rate
- Target Vessel Revascularization (TVR) rate [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
Target Vessel Revascularization (TVR) rate
- Clinically-driven Target Vessel Revascularization (CD-TVR) rate [through 3, 6, 9, 12, 24, 36, 48 and 60 months]
Clinically-driven Target Vessel Revascularization (CD-TVR) rate
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years.
-
Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
-
Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
-
Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
-
Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
-
Life expectancy >1 year in the Investigator's opinion.
-
Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
-
Total occlusions with total lesion length ≥ 40 mm.
-
Lesion must be located in the infrapopliteal arteries and above the ankle joint.
-
Multiple lesions can be treated if located in separate vessels.
-
Presence of documented run-off to the foot.
-
Inflow free from flow-limiting lesion confirmed by angiography.
-
Successful pre-dilatation of the (entire) target lesion.
Exclusion Criteria:
-
Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
-
Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
-
Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
-
Significant inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
-
Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
-
Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
-
Previous DCB procedure in the target vessel within 6 months prior to index procedure.
-
Aneurysm in the target vessel.
-
Angiographic evidence of thrombus within target limb.
-
Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis > 30%.
-
Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
-
Recent MI or stroke < 30 days prior to the index procedure.
-
Heart failure with Ejection Fraction < 30%.
-
Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
-
Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
-
Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
-
Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
-
Impaired renal function (GFR <20 mL/min) and patients on dialysis.
-
Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
-
Patient receiving systemic corticosteroid therapy.
-
Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
-
The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
-
Female subjects who are breastfeeding at the time of enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Sint Blasius | Dendermonde | East-Flanders | Belgium | 9200 |
| 2 | ZOL Genk | Genk | Limburg | Belgium | 3600 |
| 3 | Regionaal Ziekenhuis Heilig Hart | Tienen | Vlaams Brabant | Belgium | 3300 |
| 4 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 5 | Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire | Nantes | France | ||
| 6 | University Hospital Patras | Patras | Greece | ||
| 7 | IRCCS Multimedica | Sesto San Giovanni | Lombardy | Italy | 20099 |
| 8 | Maria Cecilia Hospital | Cotignola | Ravenna | Italy | 48033 |
| 9 | Ospedale San Donato | Arezzo | Italy | 50200 | |
| 10 | University Hospital Zurich | Zürich | Switzerland |
Sponsors and Collaborators
- Medtronic Endovascular
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APV-IN.PACT BTK OUS