PADOPTIMIZE BTKNCT02561299

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

A study testing Peripheral Orbital Atherectomy System and 014 Drug Coated Balloon in people with PAD and Vascular Calcification, run by Abbott Medical Devices at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: PAD, Vascular Calcification
What is being tested?: Peripheral Orbital Atherectomy System and 014 Drug Coated Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 7 sitesin 2 countries
Study dates: Sep 2015to 2 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Germany5 sites

Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen
Fürst-Strium-Klinik Bruchsal
Bruchsal
SRH Klinikum Karlsbad- Langensteinbach GmbH
Langensteinbach
Universität Leipzig
Leipzig
Romed Klinikum Rosenheim
Rosenheim

Other trials in Germany

Austria2 sites

Medical University of Graz
Graz
Vascular Clinic - Hanusch Hospital
Vienna

Other trials in Austria

About this study

Conditions: PAD, Vascular Calcification
Being tested: Peripheral Orbital Atherectomy System, 014 Drug Coated Balloon
Keywords: Drug-coated Balloons, Calcified Lesions, Orbital Atherectomy, Below the Knee, Paclitaxel, Lutonix 014 Drug-coated Balloon
Medical subject headings: Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peripheral Orbital Atherectomy SystemDevice
Orbital Atherectomy
014 Drug Coated BalloonDevice
Drug Coated Balloon

Study groups in NCT02561299
Study group	Role	What they receive
OA with adjunctive DCB angioplasty	Experimental	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Receives: Device: Peripheral Orbital Atherectomy System; Device: 014 Drug Coated Balloon
DCB angioplasty	Active comparator	014 Drug Coated Balloon angioplasty Receives: Device: 014 Drug Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months and 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 20152 Jul 2019

First posted28 Sep 2015 (estimated)
Study startSep 2015
Primary completion2 Jul 2019
Study completion2 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PADStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02561299
Sponsor's protocol ID: CLN-0007-P
Acronym: OPTIMIZE BTK
Status last verified: Jul 2023
First submitted: 26 Aug 2015
Last updated: 18 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35086385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All PAD trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
ClinicalTrials.gov ID: NCT02561299
Acronym / sponsor ID: OPTIMIZE BTK / CLN-0007-P
Conditions: PAD, Vascular Calcification
Keywords: Drug-coated Balloons, Calcified Lesions, Orbital Atherectomy, Below the Knee, Paclitaxel, Lutonix 014 Drug-coated Balloon
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Sep 2015 (actual)
Primary completion: 2 Jul 2019 (actual)
Study completion: 2 Jul 2019 (actual)
First posted: 28 Sep 2015 (estimated)
Results: Posted 16 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OA with adjunctive DCB angioplasty	Experimental	Device: Peripheral Orbital Atherectomy System, Device: 014 Drug Coated BalloonLesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
DCB angioplasty	Active comparator	Device: 014 Drug Coated Balloon014 Drug Coated Balloon angioplasty

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peripheral Orbital Atherectomy SystemOrbital Atherectomy	Device	OA with adjunctive DCB angioplasty
014 Drug Coated BalloonDrug Coated Balloon	Device	DCB angioplasty, OA with adjunctive DCB angioplasty

Primary outcome

Device Success
Time frame: During the procedure
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 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.

Results and safety

Results posted to the registry on 16 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OA With Adjunctive DCB Angioplasty	32	27
DCB Angioplasty	34	28

Primary outcome: Device Success

Time frame: During the procedure. Count of units. Unit: Drug Coated Balloons

Measure	OA With Adjunctive DCB Angioplasty n = 32	DCB Angioplasty n = 34
Value	42	39

Primary outcome: Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure

Time frame: 6 months and 12 months post-procedure. Count of units. Unit: Lesions

Measure	OA With Adjunctive DCB Angioplasty n = 32	DCB Angioplasty n = 34
Patency at 6 months	15	5
Patency at 12 months	15	6

Population analysed: Lesions with available data for patency assessment by the DUS Core Lab

Primary outcome: Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure

Time frame: 6 months and 12 months post-procedure. Number (95% Confidence Interval). Unit: % probability

Measure	OA With Adjunctive DCB Angioplasty n = 32	DCB Angioplasty n = 34
Freedom from CD-TLR at 6 months	96.8 (90.6 to 103.0)	94.1 (86.2 to 102.0)
Freedom from CD-TLR at 12 months	86.4 (74.0 to 98.8)	91.0 (81.2 to 100.7)

Primary outcome: Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure

Time frame: 6 months and 12 months post-procedure. Number (95% Confidence Interval). Unit: % probability

Measure	OA With Adjunctive DCB Angioplasty n = 32	DCB Angioplasty n = 34
Freedom from major amputation at 6 months	100.0 (100.0 to 100.0)	100.0 (100.0 to 100.0)
Freedom from major amputation at 12 months	96.6 (89.9 to 103.2)	100.0 (100.0 to 100.0)

Adverse events

Time frame: Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OA With Adjunctive DCB Angioplasty	29 of 32 (90.6%)	4 of 32 (12.5%)	2 of 32
DCB Angioplasty	22 of 34 (64.7%)	2 of 34 (5.9%)	4 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35086385Zeller 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.

Related trials for PAD

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Professor Marianne Brodmann, Dr. principal investigator

Medical University of Graz

Professor Gunnar Tepe, Dr. principal investigator

Klinikum Rosenheim Germany

Professor Thomas Zeller, Dr. principal investigator

Herz-Zentrum Bad Krozingen Germany

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral Orbital Atherectomy System and 014 Drug Coated Balloon in people with PAD and Vascular Calcification, run by Abbott Medical Devices at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Success (time frame: During the procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.