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New treatment option for Peripheral Artery Disease
Official title ACOART BTK RENEW：A Post Market Clinical Study
ClinicalTrials.gov ID: NCT04885985
What this study is testing
- What it's testing
- The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Age ≥18 years old and ≤75 years old
- 2\. Rutherford clinical category classification：3,4 or 5
- 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- 4\. Reference vessel diameter is between 2 mm and 4 mm
- 5\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all...
You likely can't join if
- 1\. Plasma creatinine clearance rate \<30 mL/min
- 2\. Acute vessel occlusion or acute thrombosis in target lesion
- 3\. Planned amputation on the target limb
- 4\. people confined to bed that are completely non-ambulatory.
- 5\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- 6\. Life expectancy \< 5 year.
See the full eligibility criteria
- 1\. Age ≥18 years old and ≤75 years old
- 2\. Rutherford clinical category classification：3,4 or 5
- 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- 4\. Reference vessel diameter is between 2 mm and 4 mm
- 5\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
- 1\. Plasma creatinine clearance rate \<30 mL/min
- 2\. Acute vessel occlusion or acute thrombosis in target lesion
- 3\. Planned amputation on the target limb
- 4\. people confined to bed that are completely non-ambulatory.
- 5\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- 6\. Life expectancy \< 5 year.
- 7\. Cumulative length of 100% occluded target lesion(s)\>150 mm
- 8\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
- 9\. History of stroke within 90 days prior to enrollment
- 10\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- 11\. Uncorrectable bleeding diathesis
- 12\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
- 13\. Pregnant or breastfeeding female people
- 14\. Ability to cross a guidewire through target lesion
- 15\. Patients who have participated in clinical trials of other medical devices or drugs during the same period
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.