AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

Peripheral Artery Disease Clinical Trial

Official title:

Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137577
• Other study ID #: acotec-03
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 17, 2020

Study information

• Verified date: June 2021
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

Description:

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia. DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 17, 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 85 years
• Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
• an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
• The expected survival time is more than 1 year
• signed Patient informed consent form

Exclusion Criteria:

• Serum creatinine clearance rate less than 30ml/min in patients
• patients with acute thrombosis requiring lysis or thrombectomy
• patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
• patient requiring intervention in both lower limbs at the same time
• In-stent restenosis in the blow-knee popliteal artery
• target lesion can't be cross by the guide wire
• the stenosis rate of proximal outflow more than 30% with or without intervention
• the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
• stenosis or occlusion of distal outflow for below-the-ankle artery.
• expected major amputations at the index limb before intervention
• known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
• patients participating in another clinical trials with interfere with this trial in the same time
• pregnancy and lactating woman
• untreatable bleeding diatheses

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Procedure:
• DEB catheter
DEB catheter (trade name: Litos/Tulip)
• common PTA balloon catheter
common PTA balloon catheter

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	People's Liberation Army General Hospital	BeiJing
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency [Time Frame: 6 months]	Freedom from target vessel occlusion and clinically driven target lesion reintervention	6 months
Secondary	device success rate	DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.	during the operation(after using the DEB catheter)
Secondary	technical success rates	The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%	during the operation(after using the DEB catheter)
Secondary	operation success rate	both device succeed and technical succeed, and without clinical complication	during the operation(after using the DEB catheter)
Secondary	if occured clinically driven TLR( target lesion revascularization)	Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers	6 months, 12 months,18 months, 24 months
Secondary	target lesion late lumen loss 6 months	measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months	6 months
Secondary	Ulcer healing rate	Healed or not, if not, improving,stagnant, worsening	6 months, 12 months
Secondary	Ulcer healing time	Healed or not	6 months, 12 months, 18 months, 24 months
Secondary	Change from baseline ankle brachial index(ABI) at 6 months	measure ankle brachial index; >1.3 Vascular wall calcification is severe; 0.9~1.1 Normal range; 0.5~0.8 Mild and moderate ischemia of lower limb arteries; <0.5 severe ischemia	6 months
Secondary	change from baseline Rutherford stage at 6 months	based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment; Stage clinical symptom; 0 asymptomatic; mild claudication; moderate claudication; severe claudication; ischemic rest pain; minor tissue loss; ulceration or gangrene	6 months, 12 months,18 months, 24 months
Secondary	limb salvage in surviving subjects	No Amputation of target limb	30 days, 6 months, 12 months,18 months, 24 months