Clinical trial NCT02561299: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Official title: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PAD
Vascular Calcification
Keywords: Drug-coated Balloons
Calcified Lesions
Orbital Atherectomy
Below the Knee
Paclitaxel
Lutonix 014 Drug-coated Balloon
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Device Success
timeFrame: During the procedure
measure: Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
timeFrame: 6 months and 12 months post-procedure
measure: Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
timeFrame: 6 months and 12 months post-procedure
measure: Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
timeFrame: 6 months and 12 months post-procedure
measure: Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
timeFrame: 6 months and 12 months post-procedure
measure: Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
timeFrame: Baseline, 6 months and 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Wien
country: Austria
facility: Vascular Clinic - Hanusch Hospital
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Bruchsal
country: Germany
facility: Fürst-Strium-Klinik Bruchsal
city: Langensteinbach
country: Germany
facility: SRH Klinikum Karlsbad- Langensteinbach GmbH
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Rosenheim
country: Germany
facility: Romed Klinikum Rosenheim
Study officials:
affiliation: Medical University of Graz, Austria
name: Professor Marianne Brodmann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Rosenheim Germany
name: Professor Gunnar Tepe, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz-Zentrum Bad Krozingen Germany
name: Professor Thomas Zeller, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeller T, Giannopoulos S, Brodmann M, Werner M, Andrassy M, Schmidt A, Blessing E, Tepe G, Armstrong EJ. Orbital Atherectomy Prior to Drug-Coated Balloon Angioplasty in Calcified Infrapopliteal Lesions: A Randomized, Multicenter Pilot Study. J Endovasc Ther. 2022 Dec;29(6):874-884. doi: 10.1177/15266028211070968. Epub 2022 Jan 27.