Trial Outcomes & Findings for Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries (NCT NCT01500031)

Last Updated: 2014-04-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

92 participants

Primary outcome timeframe

30 days

Results posted on

2014-04-15

Participant Flow

There were 92 subjects enrolled at 12 investigative centers in Belgium, Germany and Switzerland from 26 April 2012 to 16 April 2013

Participant milestones

Participant milestones
Measure	Re-ROUTE All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
Overall Study STARTED	92
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Re-ROUTE All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
Overall Study Death	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Re-ROUTE n=92 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
Age, Continuous	70.29 years STANDARD_DEVIATION 10.56 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	91 participants n=5 Participants
Region of Enrollment Belgium	36 participants n=5 Participants
Region of Enrollment Germany	53 participants n=5 Participants
Region of Enrollment Switzerland	3 participants n=5 Participants
General Medical History History of Smoking	71 participants n=5 Participants
General Medical History Current Diabetes Mellitus	47 participants n=5 Participants
General Medical History History of Hyperlipidemia requiring medication	61 participants n=5 Participants
General Medical History History of Hypertension requiring medication	75 participants n=5 Participants
General Medical History History of chronic obstructive pulmonary disease	9 participants n=5 Participants
Cardiac History History of Coronary Artery Disease	30 participants n=5 Participants
Cardiac History History of Myocardial Infarction	16 participants n=5 Participants
Cardiac History History of Congestive Heart Failure	6 participants n=5 Participants
Cardiac History Stable Angina	2 participants n=5 Participants
Cardiac History Unstable Angina	0 participants n=5 Participants
Cardiac History History of Percutaneous Coronary Intervention	16 participants n=5 Participants
Cardiac History History of Coronary Artery Bypass Graft	5 participants n=5 Participants
Neurologic/Renal History History of Transient Ischemic Attacks	0 participants n=5 Participants
Neurologic/Renal History History of Cerebrovascular Accident	11 participants n=5 Participants
Neurologic/Renal History History of Renal Insufficiency	18 participants n=5 Participants
Neurologic/Renal History History of Renal Percutaneous Intervention	0 participants n=5 Participants
Peripheral Vascular History History of Other Peripheral Interventions	40 participants n=5 Participants
Peripheral Vascular History History of Claudication	82 participants n=5 Participants
Baseline Lesion Characteristics: Treated Limb Right leg	48 lesions n=5 Participants
Baseline Lesion Characteristics: Treated Limb Left leg	44 lesions n=5 Participants
Baseline Lesion Characteristics: Reference Vessel Diameter	5.18 millimeters STANDARD_DEVIATION 0.62 • n=5 Participants
Baseline Lesion Characteristics: % Occluded	100.00 percentage Occluded STANDARD_DEVIATION 0.00 • n=5 Participants
Baseline Lesion Characteristics: Lesion Length	175.12 millimeters STANDARD_DEVIATION 85.42 • n=5 Participants
Baseline Lesion Characteristics: Presence of Calcification None/Mild	43 lesions n=5 Participants
Baseline Lesion Characteristics: Presence of Calcification Moderate	44 lesions n=5 Participants
Baseline Lesion Characteristics: Presence of Calcification Severe	5 lesions n=5 Participants
Baseline Lesion Characteristics: Percent of Lesions with Re-entry into true lumen (site reported)	84.8 percent of lesions n=5 Participants
Baseline Lesion Characteristics: Percent of Lesions with Perforation requiring intervention	4.3 percent of lesions n=5 Participants
Baseline Lesion Characteristics: Percent of Lesions with Flow limiting dissection	2.2 percent of lesions n=5 Participants
Procedural Characteristics: Primary diagnosis Claudication	78 participants n=5 Participants
Procedural Characteristics: Primary diagnosis Critical limb ischemia	14 participants n=5 Participants
Procedural Characteristics: Urgency of intervention Emergent	1 participants n=5 Participants
Procedural Characteristics: Urgency of intervention Urgent	3 participants n=5 Participants
Procedural Characteristics: Urgency of intervention Elective	88 participants n=5 Participants
Procedural Characteristics: Time from artery access to sheath removal	87.51 minutes STANDARD_DEVIATION 135.33 • n=5 Participants
Procedural Characteristics: Puncture site Right femoral	49 participants n=5 Participants
Procedural Characteristics: Puncture site Right brachial	0 participants n=5 Participants
Procedural Characteristics: Puncture site Left femoral	42 participants n=5 Participants
Procedural Characteristics: Puncture site Left brachial	0 participants n=5 Participants
Procedural Characteristics: Puncture site Other	1 participants n=5 Participants
Procedural Characteristics: Total amount of contrast used	143.11 milliliters STANDARD_DEVIATION 74.57 • n=5 Participants
Procedural Characteristics: Total fluoroscopy time	20.99 minutes STANDARD_DEVIATION 13.10 • n=5 Participants
Procedural Characteristics: Number of participants with additional Vascular procedures performed	50 participants n=5 Participants
Procedural Characteristics: Number of Participants with stent placement performed	81 participants n=5 Participants
Procedural Characteristics: Number of Participants with other Devices used	92 participants n=5 Participants
Procedural Characteristics: Number of non-target lesion treated	0.24 lesions STANDARD_DEVIATION 0.52 • n=5 Participants
Procedural Characteristics: Number of Participants currently taking medication	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Composite Rate of Major Adverse Events	3.3 percentage of participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=92 Participants Participants treated with OffRoad Re-entry Catheter System
Effectiveness (On the Day of Procedure)	84.8 percentage of participants Interval 77.4 to 92.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Device-related Death	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Device-related Perforation Requiring Intervention	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Device-related Clinically Significant Peripheral Embolism	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

All adverse events (AEs) reported by the centers.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
All Adverse Events	46 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)}

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Acute Procedure Success	73.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Target Lesion Revascularization Due to a Complication	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=90 Participants Participants treated with OffRoad Re-entry Catheter System
Device-related Dissection, Grade C or Greater	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=92 Participants Participants treated with OffRoad Re-entry Catheter System
Overall Procedure Time	87.51 minutes Standard Deviation 135.33

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

From time of "positioning balloon catheter" introduced in the body until time "final OffRoad component" removed.

Outcome measures

Outcome measures
Measure	OffRoad Re-entry Catheter n=91 Participants Participants treated with OffRoad Re-entry Catheter System
OffRoad System Use Length of Time	11.14 minutes Standard Deviation 10.49

Adverse Events

OffRoad Re-entry Catheter

Serious events: 21 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OffRoad Re-entry Catheter n=92 participants at risk Participants treated with OffRoad Re-entry Catheter System
Vascular disorders Femoral artery dissection	2.2% 2/92 • Number of events 2 • 30 days
Vascular disorders Peripheral embolism	4.3% 4/92 • Number of events 4 • 30 days
Vascular disorders Femoral artery occlusion	2.2% 2/92 • Number of events 3 • 30 days
Vascular disorders Femoral arterial stenosis	2.2% 2/92 • Number of events 2 • 30 days
Vascular disorders Peripheral artery dissection	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Arterial stenosis limb	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Arterial thrombosis limb	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Arteriovenous fistula	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Embolism	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Iliac artery stenosis	1.1% 1/92 • Number of events 1 • 30 days
General disorders Necrosis	1.1% 1/92 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.1% 1/92 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Arterial injury	1.1% 1/92 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Vascular injury	1.1% 1/92 • Number of events 1 • 30 days
Cardiac disorders Acute coronary syndrome	1.1% 1/92 • Number of events 1 • 30 days
Nervous system disorders Cerebrovascular accident	1.1% 1/92 • Number of events 1 • 30 days
Renal and urinary disorders Haematuria	1.1% 1/92 • Number of events 1 • 30 days
Hepatobiliary disorders Cholecystitis	1.1% 1/92 • Number of events 1 • 30 days
Hepatobiliary disorders Cholelithiasis	1.1% 1/92 • Number of events 1 • 30 days
Gastrointestinal disorders Diarrhoea	1.1% 1/92 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 1/92 • Number of events 1 • 30 days
General disorders Preferred Term not coded	1.1% 1/92 • Number of events 1 • 30 days

Other adverse events

Other adverse events
Measure	OffRoad Re-entry Catheter n=92 participants at risk Participants treated with OffRoad Re-entry Catheter System
Vascular disorders Femoral artery dissection	4.3% 4/92 • Number of events 4 • 30 days
Vascular disorders Peripheral artery dissection	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Hypertension	1.1% 1/92 • Number of events 1 • 30 days
Vascular disorders Reperfusion injury	1.1% 1/92 • Number of events 1 • 30 days
General disorders Oedema peripheral	2.2% 2/92 • Number of events 2 • 30 days
General disorders Catheter site haemorrhage	1.1% 1/92 • Number of events 1 • 30 days
General disorders Gait disturbance	1.1% 1/92 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.1% 1/92 • Number of events 1 • 30 days
Cardiac disorders Ventricular tachycardia	1.1% 1/92 • Number of events 1 • 30 days
Nervous system disorders Carotid artery stenosis	1.1% 1/92 • Number of events 1 • 30 days
Renal and urinary disorders Renal failure	1.1% 1/92 • Number of events 1 • 30 days
Metabolism and nutrition disorders Hyperglycaemia	1.1% 1/92 • Number of events 1 • 30 days
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/92 • Number of events 1 • 30 days

Additional Information

Director Clinical Trials

Boston Scientific

Phone: 708-771-4737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
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Restriction type: OTHER