Chronic Total Occlusion
Conditions
Brief summary
Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.
Interventions
DEVICEOffRoad Re-entry Catheter System
Facilitate the placement and positioning of guidewires within the peripheral vasculature.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Claudication or critical limb ischemia (Rutherford Category 2-5) * Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery * Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm * Minimum reference vessel diameter is 4 mm
Exclusion criteria
* Contraindication to an endovascular procedure * Previous stent placement in the target vessel * Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease * Platelet count \<150,000 mm3 or \>600,000 mm3 * Renal insufficiency with a serum creatinine \>2.3 mg/dl * History of major amputation (ankle level or above) in the same limb as the target lesion * Current participation in another drug or device clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of Major Adverse Events | 30 days | Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above). Events are based on data adjudicated by a Clinical Event Committee. |
| Effectiveness (On the Day of Procedure) | Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body | Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device-related Clinically Significant Peripheral Embolism | 30 days | All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data. |
| Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb | 30 days | All Major amputations related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data. |
| All Adverse Events | 30 days | All adverse events (AEs) reported by the centers. |
| Acute Procedure Success | 30 days | Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)} |
| Device-related Death | 30 days | All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data. |
| Device-related Dissection, Grade C or Greater | 30 days | Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material. Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles. Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material. Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow. Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen. |
| Overall Procedure Time | On the day of Procedure | Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body. |
| OffRoad System Use Length of Time | On the day of Procedure | From time of positioning balloon catheter introduced in the body until time final OffRoad component removed. |
| Target Lesion Revascularization Due to a Complication | 30 days | Any surgical or percutaneous intervention to the target lesion(s) after the index procedure. |
| Device-related Perforation Requiring Intervention | 30 days | All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data. |
Participant flow
Recruitment details
There were 92 subjects enrolled at 12 investigative centers in Belgium, Germany and Switzerland from 26 April 2012 to 16 April 2013
Participants by arm
| Arm | Count |
|---|---|
| Re-ROUTE All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Re-ROUTE |
|---|---|
| Age, Continuous | 70.29 years STANDARD_DEVIATION 10.56 |
| Baseline Lesion Characteristics: Lesion Length | 175.12 millimeters STANDARD_DEVIATION 85.42 |
| Baseline Lesion Characteristics: % Occluded | 100.00 percentage Occluded STANDARD_DEVIATION 0 |
| Baseline Lesion Characteristics: Percent of Lesions with Flow limiting dissection | 2.2 percent of lesions |
| Baseline Lesion Characteristics: Percent of Lesions with Perforation requiring intervention | 4.3 percent of lesions |
| Baseline Lesion Characteristics: Percent of Lesions with Re-entry into true lumen (site reported) | 84.8 percent of lesions |
| Baseline Lesion Characteristics: Presence of Calcification Moderate | 44 lesions |
| Baseline Lesion Characteristics: Presence of Calcification None/Mild | 43 lesions |
| Baseline Lesion Characteristics: Presence of Calcification Severe | 5 lesions |
| Baseline Lesion Characteristics: Reference Vessel Diameter | 5.18 millimeters STANDARD_DEVIATION 0.62 |
| Baseline Lesion Characteristics: Treated Limb Left leg | 44 lesions |
| Baseline Lesion Characteristics: Treated Limb Right leg | 48 lesions |
| Cardiac History History of Congestive Heart Failure | 6 participants |
| Cardiac History History of Coronary Artery Bypass Graft | 5 participants |
| Cardiac History History of Coronary Artery Disease | 30 participants |
| Cardiac History History of Myocardial Infarction | 16 participants |
| Cardiac History History of Percutaneous Coronary Intervention | 16 participants |
| Cardiac History Stable Angina | 2 participants |
| Cardiac History Unstable Angina | 0 participants |
| General Medical History Current Diabetes Mellitus | 47 participants |
| General Medical History History of chronic obstructive pulmonary disease | 9 participants |
| General Medical History History of Hyperlipidemia requiring medication | 61 participants |
| General Medical History History of Hypertension requiring medication | 75 participants |
| General Medical History History of Smoking | 71 participants |
| Neurologic/Renal History History of Cerebrovascular Accident | 11 participants |
| Neurologic/Renal History History of Renal Insufficiency | 18 participants |
| Neurologic/Renal History History of Renal Percutaneous Intervention | 0 participants |
| Neurologic/Renal History History of Transient Ischemic Attacks | 0 participants |
| Peripheral Vascular History History of Claudication | 82 participants |
| Peripheral Vascular History History of Other Peripheral Interventions | 40 participants |
| Procedural Characteristics: Number of non-target lesion treated | 0.24 lesions STANDARD_DEVIATION 0.52 |
| Procedural Characteristics: Number of Participants currently taking medication | 84 participants |
| Procedural Characteristics: Number of participants with additional Vascular procedures performed | 50 participants |
| Procedural Characteristics: Number of Participants with other Devices used | 92 participants |
| Procedural Characteristics: Number of Participants with stent placement performed | 81 participants |
| Procedural Characteristics: Primary diagnosis Claudication | 78 participants |
| Procedural Characteristics: Primary diagnosis Critical limb ischemia | 14 participants |
| Procedural Characteristics: Puncture site Left brachial | 0 participants |
| Procedural Characteristics: Puncture site Left femoral | 42 participants |
| Procedural Characteristics: Puncture site Other | 1 participants |
| Procedural Characteristics: Puncture site Right brachial | 0 participants |
| Procedural Characteristics: Puncture site Right femoral | 49 participants |
| Procedural Characteristics: Time from artery access to sheath removal | 87.51 minutes STANDARD_DEVIATION 135.33 |
| Procedural Characteristics: Total amount of contrast used | 143.11 milliliters STANDARD_DEVIATION 74.57 |
| Procedural Characteristics: Total fluoroscopy time | 20.99 minutes STANDARD_DEVIATION 13.1 |
| Procedural Characteristics: Urgency of intervention Elective | 88 participants |
| Procedural Characteristics: Urgency of intervention Emergent | 1 participants |
| Procedural Characteristics: Urgency of intervention Urgent | 3 participants |
| Race/Ethnicity, Customized Caucasian | 91 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants |
| Region of Enrollment Belgium | 36 participants |
| Region of Enrollment Germany | 53 participants |
| Region of Enrollment Switzerland | 3 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 92 |
| serious Total, serious adverse events | 21 / 92 |
Outcome results
Primary
Composite Rate of Major Adverse Events
Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above). Events are based on data adjudicated by a Clinical Event Committee.
Time frame: 30 days
Population: The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Composite Rate of Major Adverse Events | 3.3 percentage of participants |
Primary
Effectiveness (On the Day of Procedure)
Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)
Time frame: Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body
Population: The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Effectiveness (On the Day of Procedure) | 84.8 percentage of participants |
Other Pre-specified
Acute Procedure Success
Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Acute Procedure Success | 73.3 percentage of participants |
Other Pre-specified
All Adverse Events
All adverse events (AEs) reported by the centers.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | All Adverse Events | 46 adverse events |
Other Pre-specified
Device-related Clinically Significant Peripheral Embolism
All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Device-related Clinically Significant Peripheral Embolism | 0.0 percentage of participants |
Other Pre-specified
Device-related Death
All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Device-related Death | 0.0 percentage of participants |
Other Pre-specified
Device-related Dissection, Grade C or Greater
Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material. Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles. Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material. Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow. Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Device-related Dissection, Grade C or Greater | 0.0 percentage of participants |
Other Pre-specified
Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb
All Major amputations related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb | 0.0 percentage of participants |
Other Pre-specified
Device-related Perforation Requiring Intervention
All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Device-related Perforation Requiring Intervention | 0.0 percentage of participants |
Other Pre-specified
OffRoad System Use Length of Time
From time of positioning balloon catheter introduced in the body until time final OffRoad component removed.
Time frame: On the day of Procedure
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OffRoad Re-entry Catheter | OffRoad System Use Length of Time | 11.14 minutes | Standard Deviation 10.49 |
Other Pre-specified
Overall Procedure Time
Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.
Time frame: On the day of Procedure
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OffRoad Re-entry Catheter | Overall Procedure Time | 87.51 minutes | Standard Deviation 135.33 |
Other Pre-specified
Target Lesion Revascularization Due to a Complication
Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Time frame: 30 days
Population: All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OffRoad Re-entry Catheter | Target Lesion Revascularization Due to a Complication | 0.0 percentage of participants |