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

NCT02561299 | Completed Results

• 1 other identifier: CLN-0007-P
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 7

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.

Conditions

PAD; Vascular Calcification

Keywords

Drug-coated Balloons; Calcified Lesions; Orbital Atherectomy; Below the Knee; Paclitaxel; Lutonix 014 Drug-coated Balloon

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

OA with adjunctive DCB angioplasty

EXPERIMENTAL

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

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

DCB angioplasty

ACTIVE COMPARATOR

014 Drug Coated Balloon angioplasty

Device: 014 Drug Coated Balloon

Interventions

Peripheral Orbital Atherectomy System DEVICE

Orbital Atherectomy

OA with adjunctive DCB angioplasty

014 Drug Coated Balloon DEVICE

Drug Coated Balloon

DCB angioplasty; OA with adjunctive DCB angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Medical University of Graz

Graz, Austria

Location

Vascular Clinic - Hanusch Hospital

Vienna, Austria

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Location

Fürst-Strium-Klinik Bruchsal

Bruchsal, Germany

Location

SRH Klinikum Karlsbad- Langensteinbach GmbH

Langensteinbach, Germany

Location

Universität Leipzig

Leipzig, Germany

Location

Romed Klinikum Rosenheim

Rosenheim, Germany

Location

Related 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 Ther. 2022 Dec;29(6):874-884. doi: 10.1177/15266028211070968. Epub 2022 Jan 27.

  PMID: 35086385 RESULT

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Cardiovascular Systems Inc.

clintrials_csi@csi360.com

651.259.2500

Study Officials

• Professor Marianne Brodmann, Dr.

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

• Professor Gunnar Tepe, Dr.

  Klinikum Rosenheim Germany

  PRINCIPAL INVESTIGATOR

• Professor Thomas Zeller, Dr.

  Herz-Zentrum Bad Krozingen Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 28, 2015
• Study Start: September 1, 2015
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: July 18, 2023
• Results First Posted: September 16, 2021

Record last verified: 2023-07

Locations

AU (2); DE (5)