Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries

NCT03791970 | Recruiting

• 1 other identifier: AAL02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\>10cm) femoropopliteal chronic total occlusion.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency rate

  Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR

  12 months post-procedure

Secondary Outcomes (1)

• Freedom from clinically-driven TLR

  6 and 12 months post-procedure

Study Arms (2)

DCB for post-dilation

EXPERIMENTAL

DCB was used for post-dilation after stent placement. The DCB for post-dilation in this study is Orchid 035 DCB Catheter.

Device: Orchid 035 DCB Catheter

POBA for post-dilation

ACTIVE COMPARATOR

POBA was used for post-dilation after stent placement. POBA Catheter for post-dilation in this study can be Mustang, Dorado or others balloon catheters.

Device: POBA Catheter

Interventions

Orchid 035 DCB Catheter DEVICE

Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation

DCB for post-dilation

POBA Catheter DEVICE

Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation

POBA for post-dilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
• Rutherford Category 2-4;
• Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with stents placement;
• Patients must be able to be treated with DCB or POBA for post-dilation;
• Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
• At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with stents placement).
• No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
• Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
• Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.

You may not qualify if:

• Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
• Contraindication to stent or DCB or POBA per current information for use (IFU);
• Life expectancy of \<1 year;
• Inability to take required antiplatelet/anticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
• Intended treatment of outflow disease during the index procedure;
• Intended use of laser, atherectomy or cryoplasty during index procedure;
• Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
• History of stroke within 3 months;
• History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
• Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
• Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the Concern/Information Need/Participation Willingness (CIP) or confound data interpretation;
• Target vessel and/or lesion involves a previously placed stent.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (3)

Kaichuang Ye

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Minyi Yin

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Xiaobing Liu

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Xinwu Lu, MD, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Kai'chuang Ye, MD, PhD

CONTACT

+86 021-23271699-5591; ykaichuang@163.com

Xinrui Yang, MD, PhD

CONTACT

+86 021-23271699-5591; cinder_13@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 3, 2019
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)