IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Peripheral Arterial Disease Clinical Trial

Official title:

Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Standard Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963649
• Other study ID #: APV-IN.PACT BTK OUS
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: December 21, 2023

Study information

• Verified date: May 2024
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 21, 2023
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.

3. 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.

4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.

5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.

6. Life expectancy >1 year in the Investigator's opinion.

7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.

8. Total occlusions with total lesion length = 40 mm.

9. Lesion must be located in the infrapopliteal arteries and above the ankle joint.

10. Multiple lesions can be treated if located in separate vessels.

11. Presence of documented run-off to the foot.

12. Inflow free from flow-limiting lesion confirmed by angiography.

13. Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria:

1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.

2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.

3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.

4. Significant inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.

5. Failure to obtain = 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.

6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.

7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.

8. Aneurysm in the target vessel.

9. Angiographic evidence of thrombus within target limb.

10. Pre-dilatation resulted in major (= Grade D) flow-limiting dissection or residual stenosis > 30%.

11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.

12. Recent MI or stroke < 30 days prior to the index procedure.

13. Heart failure with Ejection Fraction < 30%.

14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.

15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.

16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.

17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.

18. Impaired renal function (GFR <20 mL/min) and patients on dialysis.

19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.

20. Patient receiving systemic corticosteroid therapy.

21. 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.

22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.

23. Female subjects who are breastfeeding at the time of enrollment.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• DCB
Drug Coated Balloon
• PTA
Percutaneous Transluminal Angioplasty

Locations

Country	Name	City	State
Belgium	AZ Sint Blasius	Dendermonde	East-Flanders
Belgium	ZOL Genk	Genk	Limburg
Belgium	Universitair Ziekenhuis Gent	Gent
France	Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire	Nantes
Greece	University Hospital Patras	Patras
Italy	Ospedale San Donato	Arezzo
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	IRCCS Multimedica	Sesto San Giovanni	Lombardy
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Late lumen loss (LLL) at 9 months	Late lumen loss (LLL) at 9 months	9 Months
Secondary	Composite Safety Endpoint	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.	30 days and 9 Months
Secondary	Major Adverse Event (MAE) rate	defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Status of wound healing	completely healed - improvement - unchanged - worsened	at 30 days, 3, 6, 9, 12, 24 and 36 months
Secondary	Rate of thrombosis at the target lesion	Rate of thrombosis at the target lesion	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Device success	is defined as successful drug delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).	at the time of procedure
Secondary	Clinical success	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))	up to discharge visit
Secondary	Functional flow assessment	is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound	at 3, 6, 9, 12, 24 and 36 months
Secondary	Death of any cause and cardiovascular-related deaths	Death of any cause and cardiovascular-related deaths	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Major Target Limb Amputation rate	Major Target Limb Amputation rate	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Mechanically-driven Target Lesion Revascularization (TLR) rate	Mechanically-driven Target Lesion Revascularization (TLR) rate	through 37 days
Secondary	Target Lesion Revascularization (TLR) rate	Target Lesion Revascularization (TLR) rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Clinically-driven Target Lesion Revascularization (CD-TLR) rate	Clinically-driven Target Lesion Revascularization (CD-TLR) rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Target Vessel Revascularization (TVR) rate	Target Vessel Revascularization (TVR) rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Secondary	Clinically-driven Target Vessel Revascularization (CD-TVR) rate	Clinically-driven Target Vessel Revascularization (CD-TVR) rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months