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Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study (OPTIMIZE BTK)

Primary Purpose

PAD, Vascular Calcification

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Peripheral Orbital Atherectomy System
014 Drug Coated Balloon
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAD focused on measuring Drug-coated Balloons, Calcified Lesions, Orbital Atherectomy, Below the Knee, Paclitaxel, Lutonix 014 Drug-coated Balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz
  • Vascular Clinic - Hanusch Hospital
  • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Fürst-Strium-Klinik Bruchsal
  • SRH Klinikum Karlsbad- Langensteinbach GmbH
  • Universität Leipzig
  • Romed Klinikum Rosenheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OA with adjunctive DCB angioplasty

DCB angioplasty

Arm Description

Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty

014 Drug Coated Balloon angioplasty

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2015
Last Updated
July 14, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02561299
Brief Title
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Acronym
OPTIMIZE BTK
Official Title
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD, Vascular Calcification
Keywords
Drug-coated Balloons, Calcified Lesions, Orbital Atherectomy, Below the Knee, Paclitaxel, Lutonix 014 Drug-coated Balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OA with adjunctive DCB angioplasty
Arm Type
Experimental
Arm Description
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Arm Title
DCB angioplasty
Arm Type
Active Comparator
Arm Description
014 Drug Coated Balloon angioplasty
Intervention Type
Device
Intervention Name(s)
Peripheral Orbital Atherectomy System
Intervention Description
Orbital Atherectomy
Intervention Type
Device
Intervention Name(s)
014 Drug Coated Balloon
Intervention Description
Drug Coated Balloon
Primary Outcome Measure Information:
Title
Device Success
Description
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.
Time Frame
During the procedure
Title
Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
Description
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.
Time Frame
6 months and 12 months post-procedure
Title
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
Description
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.
Time Frame
6 months and 12 months post-procedure
Title
Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
Description
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.
Time Frame
6 months and 12 months post-procedure
Title
Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
Description
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.
Time Frame
6 months and 12 months post-procedure
Title
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Description
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.
Time Frame
Baseline, 6 months and 12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Marianne Brodmann, Dr.
Organizational Affiliation
Medical University of Graz, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor Gunnar Tepe, Dr.
Organizational Affiliation
Klinikum Rosenheim Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor Thomas Zeller, Dr.
Organizational Affiliation
Herz-Zentrum Bad Krozingen Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Name
Vascular Clinic - Hanusch Hospital
City
Wien
Country
Austria
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Fürst-Strium-Klinik Bruchsal
City
Bruchsal
Country
Germany
Facility Name
SRH Klinikum Karlsbad- Langensteinbach GmbH
City
Langensteinbach
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
Country
Germany
Facility Name
Romed Klinikum Rosenheim
City
Rosenheim
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35086385
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.
Results Reference
result

Learn more about this trial

Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

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