ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in … (NCT03268018) | Clinical Trial Compass
CompletedNot Applicable
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
Belgium8 participantsStarted 2017-06-07
Plain-language summary
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient age ≥ 18 years
✓. Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
✓. Peripheral arterial disease with a documented Rutherford Class 2-5 and
✓. a resting ankle-brachial index (ABI) of \<0.9 or an abnormal exercise ABI (\<0.75) if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a toe brachial index (TBI) \<0.7 in target limb;
✓. or a previous intervention to the target vessels with reoccurrence of symptoms
✓. Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
✓. Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
✓. De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
Exclusion criteria
✕. Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
✕. Life expectancy \< 12 months
✕. Cerebrovascular accident \< 60 days prior to procedure
✕. Myocardial infarction \< 60 days prior to procedure
What they're measuring
1
Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure
Timeframe: Index procedure
2
Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.