Trial Outcomes & Findings for Ranger™ and Ranger™ SL (OTW) DCB) in China (NCT NCT02944071)
NCT ID: NCT02944071
Last Updated: 2025-10-27
Results Overview
* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
Within 30 days after treatment
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
Ranger DCB
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranger™ and Ranger™ SL (OTW) DCB) in China
Baseline characteristics by cohort
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 7.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
123 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Diabetes Mellitus (DM) History
yes
|
60 Participants
n=39 Participants
|
|
Diabetes Mellitus (DM) History
no
|
61 Participants
n=39 Participants
|
|
Diabetes Mellitus (DM) History
unknown
|
2 Participants
n=39 Participants
|
|
Coronary Artery Disease (CAD) History
|
38 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after treatmentPopulation: Device/Procedure-Related is derived from Relationship to index procedure (Possible or Probable or Causal Relationship) on Adverse Events CRF form. One subject died not-likely related to the device thus not included in the denominator.
* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization
Outcome measures
| Measure |
Ranger DCB
n=122 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Major Adverse Events Through 30 Days Post-procedure
|
121 Participants
|
PRIMARY outcome
Timeframe: Within 12 months after treatmentPopulation: 104 subjects received 12 month CTA assessment.
Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.
Outcome measures
| Measure |
Ranger DCB
n=104 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Primary Vessel Patency of the Treated Segment(s)
|
64 Participants
|
SECONDARY outcome
Timeframe: within 24 hours of the index proceduredefined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Technical Success
|
122 Participants
|
SECONDARY outcome
Timeframe: within 24 hours of the index proceduredefined as technical success with no Major Adverse Events (including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion)
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Procedural Success
|
122 Participants
|
SECONDARY outcome
Timeframe: at 3 month post index procedurePopulation: Denominators was based on the available data collected from subjects.
access the target vessel patency at 3 month visit by duplex ultrasound sonography
Outcome measures
| Measure |
Ranger DCB
n=109 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Target Vessel Patency Assessed by Duplex Ultrasound Sonography
|
97 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after treatmentPopulation: Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.
calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
All-cause Death at 30 Days, 3, 6 and 12 Months
30 days
|
1 Participants
|
|
All-cause Death at 30 Days, 3, 6 and 12 Months
3 months
|
2 Participants
|
|
All-cause Death at 30 Days, 3, 6 and 12 Months
6 months
|
2 Participants
|
|
All-cause Death at 30 Days, 3, 6 and 12 Months
12 month
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after treatmentcalculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment
Outcome measures
| Measure |
Ranger DCB
n=119 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after treatmentPopulation: Denominators was based on the available data collected for subjects.
defined as improved Rutherford classification by at least +1 class at pre-discharge, 3 and 12 months as compared to baseline. RUTHERFORD / BECKER CLASSIFICATION Category Objective Criteria 0 Normal Treadmill /stress test 1. Completes treadmill exercise; ankle pressure (AP) after exercise \< 50 mm Hg, but \> 25 mm Hg less than BP 2. Between categories 1 and 3 3. Cannot complete treadmill exercise and AP after exercise \< 50 mm Hg 4. Resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) \< 30 mm Hg 5. Nonhealing ulcer, focal gangrene with diffuse pedal edema. Resting AP \< 60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP \< 40 mm Hg 6. Extending above MT level. Same as Category 5
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Clinical Success
Pre-discharge
|
111 Participants
|
|
Clinical Success
3 months
|
103 Participants
|
|
Clinical Success
12 months
|
96 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after treatmentPopulation: Denominators was based on the available data collected from subjects.
defined as positive change in Ankle-Brachial Index at pre-discharge, 3 months, 12 months as compared to baseline. The ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: * Ankle: The systolic pressure will be measured in the target limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. * Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Hemodynamic Success
Pre-discharge
|
96 Participants
|
|
Hemodynamic Success
3 months
|
98 Participants
|
|
Hemodynamic Success
12 months
|
80 Participants
|
SECONDARY outcome
Timeframe: Within 12 months after treatmentMajor Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion
Outcome measures
| Measure |
Ranger DCB
n=123 Participants
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Major Adverse Events Through 12 Months
All Causes of death
|
3 Participants
|
|
Major Adverse Events Through 12 Months
Target Limb Major Amputation
|
1 Participants
|
|
Major Adverse Events Through 12 Months
Thrombosis at target lesion
|
2 Participants
|
|
Major Adverse Events Through 12 Months
Clinically-Driven TLR
|
3 Participants
|
Adverse Events
(Ranger & Ranger LE) and Ranger DCB
Serious events: 41 serious events
Other events: 92 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
(Ranger & Ranger LE) and Ranger DCB
n=123 participants at risk
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
3.3%
4/123 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
2/123 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
2/123 • Number of events 2 • 1 year
|
|
Eye disorders
Cataract
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Eye disorders
Retinal haemorrhage
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
1.6%
2/123 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
12.2%
15/123 • Number of events 16 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
6.5%
8/123 • Number of events 8 • 1 year
|
|
Vascular disorders
Embolism arterial
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery occlusion
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral embolism
|
0.81%
1/123 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
2.4%
3/123 • Number of events 3 • 1 year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.6%
2/123 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
(Ranger & Ranger LE) and Ranger DCB
n=123 participants at risk
The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.
Multiple interventions:
Prior to or during Index Procedure:
* Prior to treatment of the index limb, successful (\< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed
* Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed
* Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
|
|---|---|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
30.1%
37/123 • Number of events 39 • 1 year
|
|
Vascular disorders
Peripheral artery stenosis
|
20.3%
25/123 • Number of events 26 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
9/123 • Number of events 9 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
6.5%
8/123 • Number of events 8 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
5/123 • Number of events 5 • 1 year
|
|
Nervous system disorders
Dizziness
|
3.3%
4/123 • Number of events 4 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
5/123 • Number of events 5 • 1 year
|
|
Vascular disorders
Peripheral artery occlusion
|
3.3%
4/123 • Number of events 4 • 1 year
|
Additional Information
Junyang Bai
BSC International Medical Trading (Shanghai) Co., Ltd
Phone: +13671646036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60