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Use of oral colchicine to determine restenosis in the superficial femoral artery - the COLSTENT study
EU CTIS ID: 2023-508935-30-00
What this study is testing
1. Evaluation of the effectiveness of oral colchicine to prevent restenosis in the superficial femoral artery in patients with lower extremity artery disease (LEAD) treated with an uncoated vascular stent in relation to local release of paclitaxel by drug-eluting stents 2. Assessment of the tolerance and safety of oral colchicine in the treatment of restenosis in patients with LEAD treated with an uncoated vascular stent in relation to the local release of paclitaxel by drug-eluting stents.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >30 years
- Signing informed consent to taking blood samples for genetic testing
- Chronic lower limb ischemia according to the Rutherford classification (grade 3-5)
- 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
- 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
- The reference diameter of the target vessel is ≥4.0 mm and ≤7.0 mm (visual assessment)
You likely can't join if
- Previous vascular intervention in the area of the examined vessel
- 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
- Pregnancy or breastfeeding
- Presence of another serious disease (e.g. malignancy, congestive heart failure) with a life expectancy of less than 36 months
- 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)
- No consent to transfusion of blood components
See the full eligibility criteria
- Age >30 years
- Signing informed consent to taking blood samples for genetic testing
- Chronic lower limb ischemia according to the Rutherford classification (grade 3-5)
- 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
- 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
- The reference diameter of the target vessel is ≥4.0 mm and ≤7.0 mm (visual assessment)
- Patent popliteal artery and at least one patent calf artery
- Postmenopausal or surgically sterile women with a written obligation to abstain from heterosexual sexual intercourse or to use two methods of contraception
- Men with a written obligation to abstain from heterosexual sexual contact or use a contraceptive method (condom)
- Signing informed consent to participate in a clinical trial
- Previous vascular intervention in the area of the examined vessel
- 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
- Pregnancy or breastfeeding
- Presence of another serious disease (e.g. malignancy, congestive heart failure) with a life expectancy of less than 36 months
- 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)
- No consent to transfusion of blood components
- Resistance and/or allergy to clopidogrel, acetylsalicylic acid documented in the participant's medical history
- Taking colchicine for other indications (e.g. gout, familial Mediterranean fever)
- A history of an allergic reaction or significant sensitivity to colchicine
- Taking immunosuppressive drugs, e.g. cyclosporine, methotrexate
- Taking calcium channel blockers, e.g. verapamil, diltiazem
- Hemodynamically significant stenosis in the common femoral artery on the examined side
- Taking selective serotonin reuptake inhibitors (SSRIs) for diseases such as depression, anxiety, neuropathic pain
- Drug or alcohol abuse
- Inflow disorders - changes in the aorta and iliac artery (patients after intervention in the iliac arteries are allowed)
- The need to perform subintimate patency of the lesion
- Presence of an aneurysm in the femoral and popliteal arteries
- Contralateral superficial femoral artery lesions requiring intervention during the index procedure or within 30 days before or after the index procedure
- 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)
- Scheduled surgery within 30 days after the index procedure
- A planned procedure that may result in noncompliance with the protocol or interfere with the interpretation of data
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.