A prospective, single-center clinical trial has been designed with two parallel intervention groups of consecutive CLI patients (Rutherford classification 4-5) with lesions in the F-P segment. It is a single-blind study, where the patient is unaware of their group allocation, but the operator knows the group of each patient.
Patients will be randomly assigned to undergo either conventional balloon angioplasty or AngioSculpt™ scoring balloon angioplasty prior to drug-coated balloon (Luminor™) treatment.
PROCEDURE DESCRIPTION
Antithrombotic Therapy (Pre-, Intra-, and Post-Procedure):
All patients will be on at least single antiplatelet therapy prior to the procedure, receiving either aspirin (100-300 mg/day) or clopidogrel (75 mg/day).
During the procedure, an intravenous bolus of heparin (1 mg/kg body weight) will be administered.
The postprocedural antithrombotic regimen includes:
Clopidogrel: 75 mg/day starting immediately after the index procedure. Aspirin: 100-300 mg/day starting immediately after the index procedure. Dual antiplatelet therapy (DAPT) must be maintained for a minimum of 1 year following the index procedure.
Discontinuation is only permitted if a subsequent procedure requires temporary interruption of one or both antiplatelet agents. In such cases, therapy should be resumed as soon as clinically feasible.
Treatment of Non-Target Lesions:
All significant inflow-limiting lesions (≥50% stenosis) in the study limb must be treated successfully (i.e., ≤30% residual stenosis) prior to initiation of the study index procedure. Treatment should follow the institution's standard of care and reflect current evidence regarding the efficacy of available therapies.
Procedure Sequence of the Target Lesion Treatment:
1. Pre-dilatation of the lesion Pre-dilatation is mandatory and must be performed using either a standard balloon or an AngioSculpt™ scoring balloon, according to the patient's allocation group.
1. Balloon diameter must match the reference vessel diameter (RVD) in a 1:1 ratio.
2. The balloon must cover the entire length of the lesion.
3. A minimum inflation time of 180 seconds is mandatory.
4. Angiographic imaging must be recorded both before and after pre-dilatation to document the result.
2. Dilatation with Luminor™ drug-coated balloon (DCB) Following pre-dilatation, lesion treatment is completed using the Luminor™ balloon catheter.
1. A 1:1 RVD to balloon diameter ratio must be used.
2. The DCB must cover the entire lesion length and extend at least 1 cm proximally and distally beyond the area previously treated with plain balloon angioplasty.
3. A minimum inflation time of 180 seconds is mandatory.
4. Angiographic imaging must be recorded post-dilatation to assess the result.
Definition of Procedural Success.
Treatment of the target lesion is considered successful when the final angiographic result meets both of the following criteria:
1. Residual stenosis is \<30% by visual estimation, or there is no flow-limiting dissection;
2. Findings are confirmed in two angiographic projections with a minimum angulation difference of 20°.
If the angiographic result is inconclusive, intraoperative duplex ultrasonography must be performed to evaluate lesion patency and result adequacy.
Bail-Out Stenting Criteria:
In cases where the result after DCB angioplasty is inadequate, bail-out stenting is permitted using the following guidelines:
1. Spot stenting should be performed whenever possible.
2. The use of covered stents or drug-coated/drug-eluting stents is not allowed under the study protocol.
