CompletedNCT02944071Updated Oct 27, 2025Results posted

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

An interventional study of Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter in Femoropopliteal Artery Lesions, sponsored by Boston Scientific Corporation. Completed at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 123
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Femoropopliteal Artery Lesions

Browse trials for

Peripheral Arterial Disease 1,542

Keywords

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

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 123 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 123 participants (actual)

Study arms

Experimental
(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.
Device: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Mar 10, 2022

Participant flow

Participant flow — Overall Study
Milestone	Ranger DCB
Started	123
Completed	113
Not completed	10

Outcome measures

PrimaryMajor 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
Reported as:: Count of participants · Participants

Major Adverse Events Through 30 Days Post-procedure
Participants	Ranger DCB
Major Adverse Events Through 30 Days Post-procedure	121

PrimaryPrimary Vessel Patency of the Treated Segment(s)

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

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

Primary Vessel Patency of the Treated Segment(s)
Participants	Ranger DCB
Primary Vessel Patency of the Treated Segment(s)	64

SecondaryTechnical Success

defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%

Time frame:: within 24 hours of the index procedure
Reported as:: Count of participants · Participants

Technical Success
Participants	Ranger DCB
Technical Success	122

SecondaryProcedural 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)

Time frame:: within 24 hours of the index procedure
Reported as:: Count of participants · Participants

Procedural Success
Participants	Ranger DCB
Procedural Success	122

SecondaryTarget Vessel Patency Assessed by Duplex Ultrasound Sonography

access the target vessel patency at 3 month visit by duplex ultrasound sonography

Time frame:: at 3 month post index procedure
Reported as:: Count of participants · Participants

Target Vessel Patency Assessed by Duplex Ultrasound Sonography
Participants	Ranger DCB
Target Vessel Patency Assessed by Duplex Ultrasound Sonography	97

SecondaryAll-cause Death at 30 Days, 3, 6 and 12 Months

calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

All-cause Death at 30 Days, 3, 6 and 12 Months
Participants	Ranger DCB
30 days	1
3 months	2
6 months	2
12 month	3

SecondaryClinically-driven Target Lesion Revascularization at 3, 6 and 12 Months

calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months
Participants	Ranger DCB
Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months	3

SecondaryClinical Success

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

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

Clinical Success
Participants	Ranger DCB
Pre-discharge	111
3 months	103
12 months	96

SecondaryHemodynamic Success

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.

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

Hemodynamic Success
Participants	Ranger DCB
Pre-discharge	96
3 months	98
12 months	80

SecondaryMajor Adverse Events Through 12 Months

Major Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion

Time frame:: Within 12 months after treatment
Reported as:: Count of participants · Participants

Major Adverse Events Through 12 Months
Participants	Ranger DCB
All Causes of death	3
Target Limb Major Amputation	1
Thrombosis at target lesion	2
Clinically-Driven TLR	3

Adverse events

Collected over 1 year. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
(Ranger & Ranger LE) and Ranger DCB	3/123 (2.4%)	41/123 (33.3%)	92/123 (74.8%)

Most frequent serious events

Showing 10 of 27

Most frequent serious events
Event	(Ranger & Ranger LE) and Ranger DCB
Vascular procedure complicationInjury, poisoning and procedural complications	15/123
Peripheral arterial occlusive diseaseVascular disorders	8/123
Diabetic footSkin and subcutaneous tissue disorders	4/123
Coronary artery diseaseCardiac disorders	3/123
Arteriosclerosis coronary arteryCardiac disorders	2/123
HyperglycaemiaMetabolism and nutrition disorders	2/123
Pain in extremityMusculoskeletal and connective tissue disorders	2/123
Cerebral infarctionNervous system disorders	2/123
FractureInjury, poisoning and procedural complications	1/123
Hand fractureInjury, poisoning and procedural complications	1/123

Most frequent other events

Most frequent other events
Event	(Ranger & Ranger LE) and Ranger DCB
Vascular procedure complicationInjury, poisoning and procedural complications	37/123
Peripheral artery stenosisVascular disorders	25/123
Pain in extremityMusculoskeletal and connective tissue disorders	9/123
HypoaesthesiaNervous system disorders	8/123
Upper respiratory tract infectionInfections and infestations	5/123
AnaemiaBlood and lymphatic system disorders	5/123
DizzinessNervous system disorders	4/123
Peripheral artery occlusionVascular disorders	4/123

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ranger DCB
Mean	67.1 ± 7.7

Sex: Female, Male
Sex: Female, Male(Participants)	Ranger DCB
Female	36
Male	87

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ranger DCB
American Indian or Alaska Native	0
Asian	123
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	0
More than one race	0
Unknown or Not Reported	0

Diabetes Mellitus (DM) History
Diabetes Mellitus (DM) History(Participants)	Ranger DCB
yes	60
no	61
unknown	2

Coronary Artery Disease (CAD) History
Coronary Artery Disease (CAD) History(Participants)	Ranger DCB
Count of participants	38

Study locations

9 sites

Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Harbin Medicial University
Harbin, Jilin, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Xiangya Hospital Central South University
Changsha, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Tianjin Medical University General Hospital
Tianjin, China

References and documents

Publications

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Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19. PubMed 15262830 ↗
Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. doi: 10.1177/15266028060130S204. PubMed 16472007 ↗
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available. PubMed 17223489 ↗
Kasapis C, Gurm HS. Current approach to the diagnosis and treatment of femoral-popliteal arterial disease. A systematic review. Curr Cardiol Rev. 2009 Nov;5(4):296-311. doi: 10.2174/157340309789317823. PubMed 21037847 ↗
Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. J Vasc Surg. 2011 Nov;54(5):e32-58. doi: 10.1016/j.jvs.2011.09.001. Epub 2011 Sep 29. No abstract available. PubMed 21958560 ↗
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104. PubMed 17377972 ↗
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18. PubMed 20484101 ↗
Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. 2009 Aug;2(4):352-8. doi: 10.1161/CIRCINTERVENTIONS.109.873703. No abstract available. PubMed 20031739 ↗
Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1215-23. doi: 10.1001/jama.294.10.1215. PubMed 16160130 ↗
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356. PubMed 18272892 ↗
Tenaglia AN, Fortin DF, Califf RM, Frid DJ, Nelson CL, Gardner L, Miller M, Navetta FI, Smith JE, Tcheng JE, et al. Predicting the risk of abrupt vessel closure after angioplasty in an individual patient. J Am Coll Cardiol. 1994 Oct;24(4):1004-11. doi: 10.1016/0735-1097(94)90862-1. PubMed 7930190 ↗
Lincoff AM, Popma JJ, Ellis SG, Hacker JA, Topol EJ. Abrupt vessel closure complicating coronary angioplasty: clinical, angiographic and therapeutic profile. J Am Coll Cardiol. 1992 Apr;19(5):926-35. doi: 10.1016/0735-1097(92)90272-o. PubMed 1552113 ↗
Post MJ, Borst C, Kuntz RE. The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig. Circulation. 1994 Jun;89(6):2816-21. doi: 10.1161/01.cir.89.6.2816. PubMed 8205696 ↗
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. PubMed 18779447 ↗
Leiner T, Kessels AG, Nelemans PJ, Vasbinder GB, de Haan MW, Kitslaar PE, Ho KY, Tordoir JH, van Engelshoven JM. Peripheral arterial disease: comparison of color duplex US and contrast-enhanced MR angiography for diagnosis. Radiology. 2005 May;235(2):699-708. doi: 10.1148/radiol.2352040089. PubMed 15858107 ↗
Klein WM, van der Graaf Y, Seegers J, Spithoven JH, Buskens E, van Baal JG, Buth J, Moll FL, Overtoom TT, van Sambeek MR, Mali WP. Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement. Radiology. 2006 Feb;238(2):734-44. doi: 10.1148/radiol.2382041053. Epub 2005 Dec 21. PubMed 16371580 ↗
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Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313. PubMed 17470709 ↗

Study documents

Study protocol · Jul 1, 2020
Statistical analysis plan · Aug 17, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02944071
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Oct 25, 2016
Start date: Nov 24, 2016
Primary completion: Dec 22, 2020
Completion: Dec 22, 2020
Results posted: Mar 10, 2022
Last update: Oct 27, 2025

Study contacts

Zhong Chen, dr.

principal investigator · Beijing Anzehn hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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