Status:
UNKNOWN
Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID
Lead Sponsor:
Clinical Hospital Center Rijeka
Conditions:
Stable Angina
Ischemic Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwi...
Detailed Description
Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwi...
Eligibility Criteria
Inclusion
- Patients must meet ALL of the inclusion criteria:
- Clinical:
- stable angina Canadian Cardiovascular Society (CCS) 2 to 4, unstable angina, NSTEMI
- clinical and anatomic eligibility for PCI as agreed to by the local Heart Team
- in stable angina: a. ischaemic symptoms, or b. proof of ischemia on nonvasive testing, or c. positive FFR or iFR or d. ( for LMS ) IVUS minimal lumen area \<6 mm²
- patients with mental and logistical conditions for further monitoring
- patients need to accept clinical monitoring during 3 years and sign a written consent form
- patients need to be older than 18 years
- Angiographical:
- de novo bifurcational lesion with affected side branch (Medina 1,1,1; 1,0,1; 0,1,1)
- side branch diameter ≥ 2,5 mm
- LM SB-DS ≥70% and SB lesion length \> 5 mm
- non LM: SB-DS ≥ 90% and SB lesion length \> 5 mm
- side branch length ≥ 73mm
- for patients with LAD/diagonal BL - Scoring system for diagonal branches (Modified SNuHscore) ≥ 2
Exclusion
- Clinical:
- STEMI \<72 hours preceding
- Chronic total occlusion of either vessel
- SYNTAX score for planned lesions to be treated \>32
- cerebrovascular accident within 6 months, surgical procedure within one week
- pregnant/nursing women
- ejection fraction LV\< 30%, congestive heart failure, cardiogenic shock or sever valvular disease
- unfavourable long-term prognosis - patient life expectancy less than 12 months
- creatinine \> 2,0 mg/dl ( 177 mmol/L)
- hypersensibility, allergies or contraindication to: aspirin, heparin, clopidogrel, prasugel, steel, sirolimus, everolimus, zotarolimus, biolimus or contrast agents
- treatment of hyperthyroidism, administration of immunosuppressives or anticoagulant therapy, addiction to alcohol or drugs
- patients included in other clinical trials
- Angiographical:
- thrombotic lesions
- severe calcification
- patients who have had a stent implanted previously ≤ 15 mm from the current lesions which is included in the study
- lesions on the aorto-coronary venous or arterial grafts or on chronic total occlusions
- In-stent restenosis or restenosis in a segment closer than 4 mm from the target lesion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04403048
Start Date
October 1 2020
End Date
April 1 2024
Last Update
May 27 2020
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