N/A
N=66
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
PAD · Vascular Calcification
Bottom Line
View on ClinicalTrials.gov: NCT02561299 ↗Enrolled (actual)
66
Serious AEs
77.3%
Results posted
Sep 2021
Primary outcome: Primary: Device Success — 42; 39 Drug Coated Balloons
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Orbital Atherectomy System (Device); 014 Drug Coated Balloon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Success |
42; 39 | — |
| PRIMARY Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure |
15; 5; 15; 6 | — |
| PRIMARY Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure |
96.8; 94.1; 86.4; 91.0 | — |
| PRIMARY Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure |
100.0; 100.0; 96.6; 100.0 | — |
| PRIMARY Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure |
90.6; 91.2; 77.7; 85.3 | — |
| PRIMARY Change in Rutherford Category at 6 Months and 12 Months Post-Procedure |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.
Eligibility Criteria
Inclusion Criteria
- Subject's age ≥ 18 years
- Rutherford Clinical Category 3 - 5
- Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography
- Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care]
- Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length
- Target lesion length up to 20 cm
Exclusion Criteria
- Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements
- Contraindicated by either device, per Instructions For Use
- Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication)
- Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space
- Subject has more than 2 target vessels requiring treatment
- The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen
- Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication)
- Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb
- Creatinine > 2.5 mg/dL, unless on dialysis
- Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study
- Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures
- Subject is pregnant or planning to become pregnant within the study period
- Subject has an unresolved severe systemic infection
- Subject has an anticipated life span of less than one year
- Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds
- Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy
- Pre-dilatation of the target lesion prior to randomization and OA treatment
Data sourced from ClinicalTrials.gov (NCT02561299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.