Clinical trial NCT03791970: Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. 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);
3. Rutherford Category 2-4;
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;
5. Patients must be able to be treated with DCB or POBA for post-dilation;
6. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
7. 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).
8. 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;
9. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
10. Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.

Exclusion Criteria:

1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
2. Contraindication to stent or DCB or POBA per current information for use (IFU);
3. Life expectancy of \<1 year;
4. 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;
5. Intended treatment of outflow disease during the index procedure;
6. Intended use of laser, atherectomy or cryoplasty during index procedure;
7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
8. History of stroke within 3 months;
9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
10. Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
11. 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;
12. Target vessel and/or lesion involves a previously placed stent.

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Freedom from clinically-driven TLR
timeFrame: 6 and 12 months post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Kaichuang Ye
state: Shanghai
city: Shanghai
country: China
facility: Minyi Yin
state: Shanghai
city: Shanghai
country: China
facility: Xiaobing Liu
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Xinwu Lu, MD, PhD
role: STUDY_CHAIR
References: