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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02561299
Other study ID # CLN-0007-P
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date July 2, 2019

Study information

Verified date July 2023
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2, 2019
Est. primary completion date July 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Peripheral Orbital Atherectomy System
Orbital Atherectomy
014 Drug Coated Balloon
Drug Coated Balloon

Locations

Country Name City State
Austria Medical University of Graz Graz
Austria Vascular Clinic - Hanusch Hospital Wien
Germany Universitäts-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen
Germany Fürst-Strium-Klinik Bruchsal Bruchsal
Germany SRH Klinikum Karlsbad- Langensteinbach GmbH Langensteinbach
Germany Universität Leipzig Leipzig
Germany Romed Klinikum Rosenheim Rosenheim

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

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 Th — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Device Success Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used. During the procedure
Primary Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as <50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory. 6 months and 12 months post-procedure
Primary Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months. 6 months and 12 months post-procedure
Primary Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months. 6 months and 12 months post-procedure
Primary Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure. 6 months and 12 months post-procedure
Primary Change in Rutherford Category at 6 Months and 12 Months Post-Procedure Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD.
There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss.
The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.
Baseline, 6 months and 12 months post-procedure
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