DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
NCT ID: NCT05608655
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
188 participants
INTERVENTIONAL
2022-12-27
2024-02-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
NCT05894460
Drug Coated Balloons for Prevention of Restenosis
NCT00696956
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
NCT06527963
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
NCT05415995
A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
NCT04826705
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary endpoint is percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DKutting
DKutting LL Scoring Balloon, DK Medtech Co Ltd
DKutting LL balloon
After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Chocolate
Chocolate Balloon, TriReme Medical LLC
Chocolate balloon
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DKutting LL balloon
After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Chocolate balloon
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
* Rutherford clinical category-Becker class: 2 to 5
* Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
* Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
* Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
* Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.
Exclusion Criteria
* Severe calcified lesion (PACSS Grading 4)
* Guidewire cannot cross target lesion
* Amputation planned within 30 days
* In-stent restenosis
* Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
* No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
* Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
* Patient who cannot accept anticoagulant or antiplatelet therapy
* Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
* Patients who have not completed clinical trials of other drugs or devices
* Patients with poor compliance and unable to complete the study, which is identified by investigator.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DK Medical Technology (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Weiguo Fu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Hospital of Chengdu Traditional Chinese Medicine University
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
China-Japan Friendship Hospital
Beijing, , China
Xuanwu Hospital of Capital Medical University
Beijing, , China
The First Affiliated Hospital of Naval Medical University
Shanghai, , China
Zhongshan Hospital of Fudan University
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VP-P-22-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.