An interventional study of Peripheral Orbital Atherectomy System and 014 Drug Coated Balloon in PAD and Vascular Calcification, sponsored by Abbott Medical Devices. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 66 is close to the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Device: Peripheral Orbital Atherectomy System · Device: 014 Drug Coated Balloon
014 Drug Coated Balloon angioplasty
Device: 014 Drug Coated Balloon
Orbital Atherectomy
Drug Coated Balloon
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months post-procedure
| Milestone | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Started | 32 | 34 |
| Completed | 27 | 28 |
| Not completed | 5 | 6 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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.
| Drug Coated Balloons | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Device Success | 42 | 39 |
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.
| Lesions | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Patency at 6 months | 15 | 5 |
| Patency at 12 months | 15 | 6 |
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.
| % probability | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| 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) |
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.
| % probability | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| 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) |
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.
| % probability | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Freedom from MAE at 6 months | 90.6 (80.5 to 100.7) | 91.2 (81.6 to 100.7) |
| Freedom from MAE at 12 months | 77.7 (63.1 to 92.3) | 85.3 (73.4 to 97.2) |
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.
| Participants | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Baseline — Rutherford Category 0 | 0 | 0 |
| Baseline — Rutherford Category 1 | 0 | 0 |
| Baseline — Rutherford Category 2 | 0 | 0 |
| Baseline — Rutherford Category 3 | 10 | 8 |
| Baseline — Rutherford Category 4 | 2 | 4 |
| Baseline — Rutherford Category 5 | 20 | 22 |
| Baseline — Rutherford Category 6 | 0 | 0 |
| 6 months — Rutherford Category 0 | 6 | 7 |
| 6 months — Rutherford Category 1 | 5 | 1 |
| 6 months — Rutherford Category 2 | 2 | 0 |
| 6 months — Rutherford Category 3 | 1 | 1 |
| 6 months — Rutherford Category 4 | 0 | 0 |
| 6 months — Rutherford Category 5 | 8 | 8 |
| 6 months — Rutherford Category 6 | 0 | 0 |
| 12 months — Rutherford Category 0 | 10 | 8 |
| 12 months — Rutherford Category 1 | 3 | 3 |
| 12 months — Rutherford Category 2 | 2 | 1 |
| 12 months — Rutherford Category 3 | 4 | 1 |
| 12 months — Rutherford Category 4 | 0 | 0 |
| 12 months — Rutherford Category 5 | 5 | 5 |
| 12 months — Rutherford Category 6 | 0 | 0 |
Collected over Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OA With Adjunctive DCB Angioplasty | 2/32 (6.3%) | 29/32 (90.6%) | 4/32 (12.5%) |
| DCB Angioplasty | 4/34 (11.8%) | 22/34 (64.7%) | 2/34 (5.9%) |
| Event | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| New/Worsening InfectionVascular disorders | 10/32 | 5/34 |
| New/Worsening WoundVascular disorders | 8/32 | 8/34 |
| Peripheral Artery StenosisVascular disorders | 5/32 | 8/34 |
| New/Worsening PainVascular disorders | 6/32 | 2/34 |
| Peripheral Artery RestenosisVascular disorders | 4/32 | 6/34 |
| Cardiac Dysfunction-Chronic Heart Failure or AggravatedCardiac disorders | 2/32 | 5/34 |
| Myocardial InfarctionCardiac disorders | 4/32 | 0/34 |
| StrokeNervous system disorders | 4/32 | 0/34 |
| Injury/TraumaGeneral disorders | 3/32 | 4/34 |
| Urinary Tract Infection (UTI)Renal and urinary disorders | 3/32 | 1/34 |
| Event | OA With Adjunctive DCB Angioplasty | DCB Angioplasty |
|---|---|---|
| Peripheral Artery PerforationInjury, poisoning and procedural complications | 2/32 | 0/34 |
| Peripheral Artery Thrombus/ThrombosisInjury, poisoning and procedural complications | 2/32 | 0/34 |
| Blood and Lymphatic System Disorder-AnemiaGeneral disorders | 0/32 | 2/34 |
| Age, Continuous(years) | OA With Adjunctive DCB Angioplasty | DCB Angioplasty | Total |
|---|---|---|---|
| Mean | 73.4 ± 8.5 | 76.5 ± 7.1 | 75.0 ± 7.9 |
| Sex: Female, Male(Participants) | OA With Adjunctive DCB Angioplasty | DCB Angioplasty | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 26 | 25 | 51 |
| Race and Ethnicity Not Collected(Participants) | OA With Adjunctive DCB Angioplasty | DCB Angioplasty | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Rutherford Clinical Category(Participants) | OA With Adjunctive DCB Angioplasty | DCB Angioplasty | Total |
|---|---|---|---|
| Severe Claudication (3) | 10 | 8 | 18 |
| Ischemic Rest Pain (4) | 2 | 4 | 6 |
| Minor Tissue Loss (5) | 20 | 22 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2015 to primary completion in Jul 2019, 46 months.
Results were first posted in Sep 2021, 2 years 2 months after primary completion.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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