Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03791970 |
Other study ID # |
AAL02 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
January 2024 |
Source |
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
Contact |
Kai'chuang Ye, MD, PhD |
Phone |
+86 021-23271699-5591 |
Email |
ykaichuang[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for
Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries.
Patients will be selected based on the investigator's assessment, evaluation of the
underlying disease and the eligibility criteria. The patient's medical condition should be
stable, with no underlying medical condition which would prevent them from performing the
required testing or from completing the study. Patients should also be geographically stable,
willing and able to cooperate in this clinical study and remain available for long-term
follow-up. A patient is considered enrolled in the study after obtaining the patients
informed consent, if there is full compliance with the study eligibility criteria and after
successful stent angioplasty for the occluded femoropopliteal arteries.
Prior to the index procedure the following tests and clinical data will be collected:
informed consent for data collection, demographics, medical history, medication record,
physical examination, clinical category of chronic limb ischemia (Rutherford category) and
resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard
clinical practice. After successful lesion passage, diagnostic angiography of the lesion area
and distal run-off is performed and angiographic measurements (vessel diameter, percentage
stenosis and lesion length) are collected. All inflow-limiting lesion will be treated
according to the investigators standard clinical practice before treatment of the target
lesion. The study compares 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. The indication for stent placement is based
on the investigator's assessment. An expected total of 180 patients will be treated in the
scope of this study. The lesion is located within the native superficial femoral artery
and/or the popliteal artery. Prior to stents placement, pre-dilatation with the POBA balloon
is mandatory. After stents placement, post-dilatation with the Orchid 035 DCB or POBA need to
be performed. Patients will be invited for a follow-up visit at 1, 6 and 12 month
post-procedure. The primary efficacy endpoint of the study is defined as the freedom from
clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints
include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6
months, clinical success at 1, 6 and 12 months and freedom from serious adverse events at
pre-discharge, 1, 6 and 12 months follow-up.No other adjunctive therapies (atherectomy,
laser) are allowed. The complete femoropopliteal vasculature should be treated in one single
session, staged interventions are not allowed. All outflow-limiting lesions must be treated
according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the
procedure. Patients will be invited for a follow-up visit at 1, 6 and 12 months after the
index procedure. The following data will be collected during these follow-up visit:
medication record, physical examination, rutherford categorization, ABI and color flow
doppler ultrasound.