Feasibility Study of Medtronic Drug-Coated Balloon Technology for Challenging Below-the-Knee Disease Shows Promise in Patients with Critical Limb Ischemia
“The design of this feasibility study is incredibly thorough, and required rigorous procedural, duplex ultrasound, and angiographic protocols to more accurately evaluate these complex lesions,” said
The IN.PACT BTK study is a prospective, multi-center, 1:1, randomized feasibility study assessing the safety and effectiveness of the IN.PACT 0.014 DCB, a 3.5 μg/mm2 dose paclitaxel-coated balloon, versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries. The study enrolled 50 subjects at nine sites in
The effectiveness endpoint evaluated nine-month late lumen loss, an angiographic measurement comparing the post-procedure lumen diameter with the lumen diameter at nine months, specifically sub-segmental late lumen loss, or lumen loss assessed along the entirety of the lesion; and classic late lumen loss, or lumen loss measured at the single narrowest segment of the artery. The safety endpoint evaluated a composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation within nine months, and freedom from clinically driven target limb revascularization (CD-TLR) within nine months post-index procedure.
At nine months, subjects in the DCB group experienced a reduction in sub-segmental late lumen loss compared to those in the PTA control group (0.59mm +/-0.94mm versus 1.26mm +/- 0.81mm respectively, p=0.017), a 53% lower late lumen loss than the PTA control group. Using the classic late lumen loss method, subjects in the DCB group experienced lower late lumen loss compared to those in the PTA control group at nine months (0.89mm +/- 0.77mm versus 1.31mm +/- 0.72mm respectively, p=0.07 ), a 32% lower late lumen loss than the PTA control group.
There was no statistical difference in the safety composite endpoint within nine months between the DCB group and PTA control group (91.3% versus 87.5% respectively; p=1.000). Safety outcomes by category included a freedom-from:
- Device and procedure-related death through 30 days: 0.0% in the DCB group compared to 3.7% in the PTA control group (p=1.000)
- Target limb Major amputation within 270 days: 0.0% in the DCB group compared to 0.0% in the PTA control group (p>0.999)
- CD-TLR within 270 days: 8.7% in the DCB group compared to 8.7% in the PTA control group (p=1.000)
“As a result of our learnings from the earlier IN.PACT DEEP study, we now have a better understanding of this challenging vessel bed, as well as deep expertise in BTK clinical trial and product design,” said
Historically, there has not been a DCB technology that has demonstrated effectiveness in this vessel bed. The data presented today demonstrate that IN.PACT 0.014 may offer a clinical benefit in patients with CLI. Previously, Medtronic conducted the IN.PACT DEEP study, which evaluated the safety and effectiveness of the previous generation IN.PACT™ Amphirion DCB, and has published data out to five-years. That study did not meet its effectiveness endpoint, which resulted in the decision to remove IN.PACT Amphirion DCB from the market in 2013. Notably, the IN.PACT 0.014 DCB, utilized in the current IN.PACT BTK study, uses the same DCB formulation that has demonstrated effectiveness in the IN.PACT™ Admiral and IN.PACT™ AV DCB clinical programs.
“Today’s milestone is the result of a close partnership between Medtronic and the clinical community to design a thoughtful BTK study to assess how the IN.PACT 0.014 DCB works on some of the most challenging lesions in critically ill patients with BTK disease,” said
The IN.PACT 0.014 DCB is an investigational device that is being evaluated in
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the
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