COLCHICINE for Lower extremity artery disease

Inclusion criteria

• {"criterion_text":"- Age >30 years\n- Signing informed consent to taking blood samples for genetic testing\n- Chronic lower limb ischemia according to the Rutherford classification (grade 3-5)\n- Arteriographically diagnosed lesion in the superficial femoral artery l in the TASC A or TASC B classification, with occlusion or de novo lesion and/or restenosis of the superficial femoral artery ≥50% and ankle-brachial index (ABI) <0.90\n- Target lesion located at least 1 cm distal to the origin of the deep femoral artery and to the proximal border of the popliteal artery, not exceeding 3 cm above the patella\n- The reference diameter of the target vessel is ≥4.0 mm and ≥7.0 mm (visual assessment)\n- Patent popliteal artery and at least one patent calf artery\n- Postmenopausal or surgically sterile women with a written obligation to abstain from heterosexual sexual intercourse or to use two methods of contraception\n- Men with a written obligation to abstain from heterosexual sexual contact or use a contraceptive method (condom)\n- Signing informed consent to participate in a clinical trial"}

Exclusion criteria

• {"criterion_text":"- Previous vascular intervention in the area of the examined vessel\n- A trial participant is participating in another clinical trial involving drugs or devices that did not meet its primary endpoint or that, in the investigator's opinion, may result in noncompliance with the protocol or affect the interpretation of data\n- Pregnancy or breastfeeding\n- Presence of another serious disease (e.g. malignancy, congestive heart failure) with a life expectancy of less than 36 months\n- Presence of another serious chronic disease: kidney diseases (eGFR <50 ml/min), liver diseases (ALT >3 x normal, AST >3 x normal, bilirubin 3 x normal), chronic hepatitis B or C, HIV infection, hyperuricemia (URCA > upper limit of normal laboratory), creatine kinase level (> 4 x normal), blood diseases (leukopenia, granulocytopenia, anemia, thrombocytopenia), coagulation disorders, autoimmune diseases, inflammatory bowel disease, ulcerative colitis, comorbidities requiring chronic use of steroid drugs (chronic obstructive lung disease, asthma, rheumatoid arthritis) or non-steroidal anti-inflammatory drugs (NSAIDs)\n- No consent to transfusion of blood components\n- Resistance and/or allergy to clopidogrel, acetylsalicylic acid documented in the participant's medical history\n- Taking colchicine for other indications (e.g. gout, familial Mediterranean fever)\n- A history of an allergic reaction or significant sensitivity to colchicine\n- Taking immunosuppressive drugs, e.g. cyclosporine, methotrexate\n- Taking calcium channel blockers, e.g. verapamil, diltiazem\n- Hemodynamically significant stenosis in the common femoral artery on the examined side\n- Taking selective serotonin reuptake inhibitors (SSRIs) for diseases such as depression, anxiety, neuropathic pain\n- Drug or alcohol abuse\n- Inflow disorders - changes in the aorta and iliac artery (patients after intervention in the iliac arteries are allowed)\n- The need to perform subintimate patency of the lesion\n- Presence of an aneurysm in the femoral and popliteal arteries\n- Contralateral superficial femoral artery lesions requiring intervention during the index procedure or within 30 days before or after the index procedure\n- The target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and atherectomy may be used during the index procedure)\n- Scheduled surgery within 30 days after the index procedure\n- A planned procedure that may result in noncompliance with the protocol or interfere with the interpretation of data"}

Primary endpoints

• {"endpoint_text":"- Patency of the superficial femoral artery after 24 months. Number of patients in whom the superficial femoral artery remained patency, i.e. blood flow in the artery assessed by Doppler ultrasound examination is three-phase and fast-flow 24 months after its implantation","definition_or_measurement_approach":"Assessed by Doppler ultrasound examination: blood flow in the artery is three-phase and fast-flow at 24 months after implantation"}
• {"endpoint_text":"- Overall risk assessment of the procedure performed, defined as the number of subjects who experienced adverse events (AEs and SAEs), regardless of the potential connection with the stent implantation procedure or the pharmacotherapy used.","definition_or_measurement_approach":"Count of subjects who experienced adverse events (AEs and SAEs), irrespective of relationship to stent implantation or pharmacotherapy"}

Secondary endpoints

• {"endpoint_text":"- Target Vessel Revascularization (TVR) over 24 months. Number of patients whose target vascular lesion in the superficial femoral artery required repeated revascularization within 24 months of stent implantation.","definition_or_measurement_approach":"Count of patients requiring repeated revascularization of the target lesion within 24 months of stent implantation"}
• {"endpoint_text":"- Late Lumen Loss (LLL) after 6 months. The value of the difference in mm between the minimum lumen diameter (MLD) in the stent immediately after stenting and the MLD 6 months after stent implantation.","definition_or_measurement_approach":"Measured in mm: difference between MLD immediately post-stenting and MLD at 6 months"}
• {"endpoint_text":"- Percentage narrowing of the vessel diameter in the stent after 24 months. Change estimated in % of the minimum lumen diameter in the stent (MLD) immediately after stenting and 24 months after stent implantation, determined by the formula [1−(MLD/reference vessel diameter)×100]","definition_or_measurement_approach":"Calculated percentage change: [1 - (MLD / reference vessel diameter) × 100] comparing MLD immediately after stenting and at 24 months"}
• {"endpoint_text":"- Improvement of the ankle-brachial index (ABI) after 24 months. Number of patients with an increase in the ankle-brachial index value by 0.1 during 24 months after stent implantation.","definition_or_measurement_approach":"Count of patients with ABI increase ≥0.1 from baseline within 24 months"}
• {"endpoint_text":"- Improved Rutherford ischemia classification after 24 months. Number of patients whose ischemia classification on the Rutherford scale was reduced by one class within 24 months after stent implantation.","definition_or_measurement_approach":"Count of patients with a one-class or greater reduction on the Rutherford scale within 24 months"}
• {"endpoint_text":"- Occurrence of major amputation after 24 months. Number of patients who underwent amputation involving detachment of the ankle joint, amputation below/above the knee within 24 months of stent implantation.","definition_or_measurement_approach":"Count of patients undergoing major amputation (ankle joint detachment, below/above knee) within 24 months"}
• {"endpoint_text":"- Major adverse cardiovascular events (MACE) after 24 months. Number of patients who experienced myocardial infarction, coronary revascularization, ischemic stroke or death from cardiovascular causes within 24 months after stent implantation","definition_or_measurement_approach":"Count of patients experiencing MI, coronary revascularization, ischemic stroke, or cardiovascular death within 24 months"}
• {"endpoint_text":"- Occurrence of death from cardiovascular causes after 24 months. Number of patients who died of cardiovascular causes within 24 months after stent implantation.","definition_or_measurement_approach":"Count of deaths from cardiovascular causes within 24 months"}
• {"endpoint_text":"- Number of days of hospitalization (all causes) during 24 months. Number of days of hospitalization of the patient for any reason within 24 months after stent implantation","definition_or_measurement_approach":"Total days of hospitalization for any cause per patient during 24 months"}
• {"endpoint_text":"- Number of hospitalization days related to LEAD in the stented leg during 24 months. Number of days of patient hospitalization related to LEAD in the leg with an implanted stent, including repeated revascularization, amputation, etc. within 24 months of implantation","definition_or_measurement_approach":"Total days of hospitalization related to LEAD in the stented leg (including procedures) during 24 months"}
• {"endpoint_text":"- Improvement in ischemic pain intensity assessed using the NRS scale after 24 months. Reduction in the intensity of ischemic pain assessed using the NRS scale in relation to baseline values by 10 pp in the period of 24 months after stent implantation","definition_or_measurement_approach":"Change in NRS pain score: reduction of 10 percentage points relative to baseline within 24 months"}
• {"endpoint_text":"- Improvement in quality of life assessed using the VascuQol protocol at 24 months. An increase in the quality of life assessed using the VascuQol scale during the study compared to the baseline values by 10 pp in the 24 months after stent implantation","definition_or_measurement_approach":"Change in VascuQol score: increase of 10 percentage points relative to baseline within 24 months"}

Poland

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

28-07-2025

Processing Time Days

472

Number Of Sites

8

Number Of Participants

284

Primary sponsor

Full Name

Uniwersytecki Szpital Kliniczny W Opolu

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Instytut Genetyki Człowieka PAN","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Educational Institution"}