Ranger™ and Ranger™ SL (OTW) DCB) in China

Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02944071

Enrollment

123

Registered

2016-10-25

Start date

2016-11-24

Completion date

2020-12-22

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoropopliteal Artery Lesions

Keywords

femoropopliteal artery lesions, Percutaneous Transluminal Angioplasty, Peripheral Artery Disease, Drug-coated Balloon

Brief summary

This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Ranger DCB catheter. Approximately 123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to participate.

Detailed description

study objectives: The primary objective of this study is to demonstrate acceptable safety and performance of the Ranger™（Ranger & Ranger LE） and Ranger™ SL (OTW) paclitaxel-coated PTA balloon catheter used for angioplasty of femoropopliteal artery lesions. Primary endpoints: The primary safety endpoint is the rate of following major adverse events through 30 days post-procedure: * all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization (TLR) The primary efficacy endpoint is primary lesion patency of the treated segment(s) as assessed by computed tomography angiography (CTA) at 12 months post-procedure without clinically-driven TLR.

Interventions

DEVICEBoston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects must be age 18 or older * Subject is willing and able to provide informed consent * Subject is available and willing to attend all required follow-up visits * Subject has a clinically significant symptomatic leg ischemia * Subject has a Rutherford clinical category of 2 - 4 * If the index lesion is restenotic, the prior PTA must have been \> 90 days prior to treatment in the current study * Only one lesion per limb can be treated under this protocol, which means that one index lesion, on one index limb will be in treatment. However, both limbs may be treated during either the index procedure and/or subsequent procedures * Successful intraluminal wire crossing of the target lesion Angiographic Inclusion Criteria: * Al1.The index lesion is a clinically and hemodynamically de novo stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery between the Hunter's Canal and the popliteal fossa (i.e. within the P1 segment), with the following characteristics by visual assessment: * Degree of stenosis ≥ 70% * Target vessel diameter ≥ 2.0 mm and ≤ 8.0 mm * Lesion length ≥ 20 mm and ≤ 200 mm, to be covered by one or two balloon(s) (with minimal overlap) * For diffuse lesion or multiple lesions in the same target vessel, the total lesion length, including the distance between lesions, must be ≤ 200 mm * AI2. The subject has at least one patent infrapopliteal artery (\< 50% stenosis) to the foot prior to index procedure

Exclusion criteria

* Subjects who have undergone prior vascular surgery of the SFA/PPA（Superficial Femoral Artery / Proximal Popliteal Artery） in the index limb to treat atherosclerotic disease * History of major amputation in the same limb as the target lesion * Presence of aneurysm in the target vessel(s) * Acute ischemia and/or acute thrombosis in any artery of the lower limbs * Acute Myocardial Infarction within 30 days before the index procedure * History of hemorrhagic stroke within 3 months * History of thrombolysis or angina within 2 weeks of enrollment * Persistent, intraluminal thrombus of the proposed target lesion post thrombolytic therapy * Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated * Known allergies against Paclitaxel or other components of the used medical devices * Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial * Platelet count \< 80,000 mm3 or \> 700,000 mm3 * Concomitant renal failure with a serum creatinine \> 2.0 mg/dL * Receiving dialysis or immunosuppressant therapy * Life expectancy of less than one year * Women of child-bearing potential cannot use a reliable method of contraception from the time of screening through 12 months after the index procedure. * Woman who is pregnant or nursing. (Pregnancy test must be performed within 72 hours prior to the index procedure, except for women who definitely do not have child-bearing potential). * Previously planned stenting of the index lesion (stents will be allowed for bailout situations like flow-limiting dissection) * Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry devices) * Subjects who had any major procedures (cardiac, aorta, peripheral) within 30 days prior to the index procedure * Planned or expected procedures (cardiac, aorta, peripheral) within 30 days post the index procedure * Presence of outflow lesions requiring intervention within 30 days of the index procedure * Perforated vessel as evidenced by extravasation of contrast media * Heavily calcified target lesions resistant to PTA * Current participation in another drug or device trial that has not completed the primary endpoint, including any clinical study using drug-coated or drug-eluting technology, that may potentially confound the results of this trial, or that would limit the subject's compliance with the follow-up requirements * Current or past intervention using drug-coated/drug-eluting technologies in the index limb * Target lesion with in-stent restenosis (any stent or stent-graft) Angiographic

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Events Through 30 Days Post-procedure	Within 30 days after treatment	* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization
Primary Vessel Patency of the Treated Segment(s)	Within 12 months after treatment	Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.

Secondary

Measure	Time frame	Description
Target Vessel Patency Assessed by Duplex Ultrasound Sonography	at 3 month post index procedure	access the target vessel patency at 3 month visit by duplex ultrasound sonography
All-cause Death at 30 Days, 3, 6 and 12 Months	Within 12 months after treatment	calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment
Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months	Within 12 months after treatment	calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment
Technical Success	within 24 hours of the index procedure	defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Hemodynamic Success	Within 12 months after treatment	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.
Major Adverse Events Through 12 Months	Within 12 months after treatment	Major Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion
Clinical Success	Within 12 months after treatment	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
Procedural Success	within 24 hours of the index procedure	defined 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)

Countries

China

Participant flow

Participants by arm

Arm	Count
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	123
Total	123

Arm

Count

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

123

Total

123

Baseline characteristics

Characteristic	Ranger DCB
Age, Continuous	67.1 years STANDARD_DEVIATION 7.7
Coronary Artery Disease (CAD) History	38 Participants
Diabetes Mellitus (DM) History no	61 Participants
Diabetes Mellitus (DM) History unknown	2 Participants
Diabetes Mellitus (DM) History yes	60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	123 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	87 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 123
other Total, other adverse events	92 / 123
serious Total, serious adverse events	41 / 123

Outcome results

Primary

Major Adverse Events Through 30 Days Post-procedure

* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization

Time frame: Within 30 days after treatment

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Ranger DCB	Major Adverse Events Through 30 Days Post-procedure	121 Participants

Primary

Primary Vessel Patency of the Treated Segment(s)

Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.