Ranger™ and Ranger™ SL (OTW) DCB) in China | NCT02944071

NCT02944071

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(Ranger & Ranger LE) and Ranger DCB	Experimental	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.	Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

Name	Type	Description	Arm Group Labels	Other Names
Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter	Device		(Ranger & Ranger LE) and Ranger DCB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Within 30 days after treatment
Primary Vessel Patency of the Treated Segment(s)	Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.	Within 12 months after treatment

Secondary Outcomes

Measure	Description	Time Frame
Technical Success	defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%	within 24 hours of the index procedure
Procedural Success	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)

Eligibility Module

Eligibility Criteria

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 Exclusion Criteria:

AE1. Subjects with ipsilateral iliac inflow lesions , and unsuccessful treatment prior to the index procedure (i.e., residual stenosis ≥ 30% post treatment
AE2. Subjects with no patent infrapopliteal artery (i.e., ≥ 50% stenosis) to the foot prior to index procedure

Name	Affiliation	Role
Zhong Chen, dr.	Beijing Anzehn hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital, Capital Medical University		Beijing	Beijing Municipality		China
The First Affiliated Hospital of Zhengzhou University

PubMed Identifier	Type	Citation	Retractions
3156006	Background	Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5. doi: 10.1161/01.cir.71.3.510.
7867189	Background	Hiatt WR, Hoag S, Hamman RF. Effect of diagnostic criteria on the prevalence of peripheral arterial disease. The San Luis Valley Diabetes Study. Circulation. 1995 Mar 1;91(5):1472-9. doi: 10.1161/01.cir.91.5.1472.

ID	Title	Description
FG000	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

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

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

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.

Posted

Count of Participants

Participants

Within 30 days after treatment

ID	Title	Description
OG000	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

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	(Ranger & Ranger LE) and 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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 1, 2020	Jan 19, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 17, 2020	Jan 19, 2022	SAP_001.pdf

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