Complete Lesion Assessment With ffR and IVUS TechnologY | NCT01941030

NCT01941030

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Orbital Atherectomy System	Experimental	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)	Device: Orbital Atherectomy System Device: Balloon Angioplasty
Balloon Angioplasty	Active Comparator	Balloon Angioplasty (BA) alone	Device: Balloon Angioplasty

Name	Type	Description	Arm Group Labels	Other Names
Orbital Atherectomy System	Device	Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)	Orbital Atherectomy System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS	The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.	Post-balloon angioplasty
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS	The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.	Pre-intervention, and post-balloon angioplasty
Change in Plaque Area as Assessed by IVUS	The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.	Pre-intervention, and post-balloon angioplasty
Change in Dense Calcium Area as Assessed by IVUS	The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.	Pre-intervention, and post-balloon angioplasty
Change in Necrotic Core Area as Assessed by IVUS	The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.	Pre-intervention, and post-balloon angioplasty
Change in Fibrous Plaque Area as Assessed by IVUS	The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.	Pre-intervention, and post-balloon angioplasty

Secondary Outcomes

Measure	Description	Time Frame
Fractional Flow Reserve	Fractional flow reserve (FFR) will be measured to assess hemodynamic function following each device procedure. During FFR, adenosine will be given through the femoral artery sheath or access catheter in two doses: 600 mcg and 1200 mcg. A higher FFR is presumed to correlate to better flow which may improve wound healing.	Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

Subject's age ≥ 18 years.
Subject is an acceptable candidate for percutaneous intervention with the Sponsor's OAS and BA in accordance with their labeled indications and instructions for use.
Subject is willing and able to sign an approved informed consent form (ICF).
Subject is willing and able to attend follow-up and wound care visits.

General Exclusion Criteria:

Subject is pregnant or planning to become pregnant within the study period.
Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this trial.
Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated.
Uncontrolled allergy to nitinol, stainless steel, or other stent materials.
Subject has known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide.
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Subject has been diagnosed with chronic renal failure or has a creatinine level > 2.5, unless on dialysis, prior to the index treatment.
Subject has evidence of intracranial or gastrointestinal bleeding within 90 days.
Subject has a history of trauma, fracture, major surgery (includes major amputation), or biopsy of a parenchymal organ within past 14 days, or patient has not healed from a previous medical intervention occurring more than 14 days.
Subject has a history of stroke or myocardial infarction (MI) within 90 days prior to enrollment in the study.
Subject has a planned major surgery (includes major amputation) scheduled within 60 days after treatment of the index limb.
Subject has a planned interventional treatment to address stenosis of the contralateral limb scheduled within 60 days after the index treatment.
Subject has a planned interventional treatment to address inflow stenosis of the ipsilateral limb scheduled within 60 days after the index treatment.
Inflow or bilateral PAD requiring treatment prior to enrollment was not successfully treated, defined as > 50% residual stenosis and/or occurrence of procedural angiographic complications, excluding dissection types A and B.
Subject has previously had their other limb treated as part of the study.

Angiographic Inclusion Criteria:

Target lesion(s) located in the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT) or peroneal (PR) arteries.
Target lesion has ≥ 50 % stenosis by angiography.
Subject has a corresponding wound being fed by the target vessel.

Angiographic Exclusion Criteria:

Target limb does not have any visual flow to the foot confirmed via distal selective angiography.
Thrombus is present or suspected in the target treatment vessel.
Target lesion is within a bypass graft or near a previously placed stent.
The guide wire cannot be passed across the target lesion.
Anterograde access of the lesion is not possible.
Subject has angiographic evidence of significant dissection at or near the treatment site.
Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
Subject's wound(s) involve multiple angiosomes.

Name	Affiliation	Role
Raymond Dattilo, M.D.	St. Francis Heart and Vascular Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Heart Clinic		Little Rock	Arkansas	72211	United States
Northside Hospital

ID	Title	Description
FG000	Orbital Atherectomy System	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
FG001	Balloon Angioplasty	Balloon Angioplasty (BA) alone Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Orbital Atherectomy System	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS

The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.

Not all subjects had reported IVUS data for each lesion pre- and post-treatment.

Posted

Median

Inter-Quartile Range

percentage of lumen gain

Post-balloon angioplasty

lesions

ID	Title	Description
OG000	Orbital Atherectomy System	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Orbital Atherectomy System	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.

ID	Term
D058729	Peripheral Arterial Disease
D000089802	Chronic Limb-Threatening Ischemia

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D017130	Angioplasty
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures