Coronary Artery Disease Clinical Trial
— PRO-DAVIDOfficial title:
Rationale and Design of a Prospective, Open Label, Randomized, Multicentric Clinical Trial: Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID
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 stepwise provisional stent strategy with main branch-only stenting
followed by provisional balloon angioplasty with or without stenting of the side branch (SB).
Stenting of the side branch is indicated when the angiographic result in SB is clearly
suboptimal and when flow remains reduced. Upfront use of two stent techniques may be
indicated in very complex lesions with large calcified side branches ( most likely to supply
at least 10% of fractional myocardial mass), with a long ostial side branch lesion (>5mm) or
anticipated difficulty in accessing an important side branch after main branch stenting, and
true distal LM bifurcations.
From a technical point of view, we propose a "Provisional DCB approach" that differs from the
standard provisional approach with obligatory SB predilation and good lesion preparation. In
case of an adequate result of predilation, the procedure on the SB ends with the DCB
deployment. This is followed by main branch stenting with DES, finished with POT. Final
'kissing' balloon dilation is generally not recommended because there is no advantage from
final kissing with the one-stent technique. With this approach, there is no need for
re-wiring, re-ballooning, side branching and wire jailing and final kissing. This technique
is close to a contemporary approach to bifurcation lesions based on the fundamental
philosophy of the European Bifurcation Club (EBC): keep it simple, systematic, and safe, with
a limited number of stents that should be well apposed and expanded with limited overlap,
with respect of the original bifurcation anatomy.
Status | Not yet recruiting |
Enrollment | 800 |
Est. completion date | April 2024 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Patients must meet ALL of the inclusion criteria: Clinical: 1. stable angina Canadian Cardiovascular Society (CCS) 2 to 4, unstable angina, NSTEMI 2. clinical and anatomic eligibility for PCI as agreed to by the local Heart Team 3. 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 4. patients with mental and logistical conditions for further monitoring 5. patients need to accept clinical monitoring during 3 years and sign a written consent form 6. patients need to be older than 18 years Angiographical: 1. de novo bifurcational lesion with affected side branch (Medina 1,1,1; 1,0,1; 0,1,1) 2. side branch diameter = 2,5 mm 3. LM SB-DS =70% and SB lesion length > 5 mm 4. non LM: SB-DS = 90% and SB lesion length > 5 mm 5. side branch length = 73mm 6. for patients with LAD/diagonal BL - Scoring system for diagonal branches (Modified SNuHscore) = 2 Exclusion Criteria: Clinical: 1. STEMI <72 hours preceding 2. Chronic total occlusion of either vessel 3. SYNTAX score for planned lesions to be treated >32 4. cerebrovascular accident within 6 months, surgical procedure within one week 5. pregnant/nursing women 6. ejection fraction LV< 30%, congestive heart failure, cardiogenic shock or sever valvular disease 7. unfavourable long-term prognosis - patient life expectancy less than 12 months 8. creatinine > 2,0 mg/dl ( 177 mmol/L) 9. hypersensibility, allergies or contraindication to: aspirin, heparin, clopidogrel, prasugel, steel, sirolimus, everolimus, zotarolimus, biolimus or contrast agents 10. treatment of hyperthyroidism, administration of immunosuppressives or anticoagulant therapy, addiction to alcohol or drugs 11. patients included in other clinical trials Angiographical: 1. thrombotic lesions 2. severe calcification 3. patients who have had a stent implanted previously = 15 mm from the current lesions which is included in the study 4. lesions on the aorto-coronary venous or arterial grafts or on chronic total occlusions 5. In-stent restenosis or restenosis in a segment closer than 4 mm from the target lesion |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Clinical Hospital Center Rijeka |
Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study. PLoS One. 2016 Jan 29;11(1):e0147057. doi: 10.1371/journal.pone.0147057. eCollection 2016. — View Citation
Banning AP, Lassen JF, Burzotta F, Lefèvre T, Darremont O, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club. EuroIntervention. 2019 May 20;15(1):90-98. doi: 10.4244/EIJ-D-19-00144. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who develop major adverse cardiac events | Defined as cardiac death, myocardial infarction unrelated to the procedure which demanded hospitalization, revascularization of the target lesion | 12 months after the procedure | |
Secondary | Number of patients who develop an individual component of the primary endpoint | cardiac death, myocardial infarction unrelated to the procedure which demanded hospitalization, revascularization of the target lesion | 12 months and 36 months after the procedure | |
Secondary | Rate of angiographic success | residual stenosis - main blood vessel =10%, side branch vessel: =30%, visual assessment of quantitative angiography, TIMI 3 flow in both treated blood vessels, no flow-limiting dissection, distal embolization or thrombus seen on angiography | immediately after the procedure | |
Secondary | Rate of procedural success | angiographic success without intrahospital MACE which include death, infarction with ST elevation or emergency bypass surgery | immediately after the procedure | |
Secondary | Rate of possible, probable or definitive stent thrombosis | ARC definition | 12 months after the procedure | |
Secondary | Rate of in segment late lumen loss in any of the treated branches | standard definition | 9 months after the procedure | |
Secondary | Rate of "bailout" stenting and inadequate predilatation | standard definition | immediately after the procedure | |
Secondary | Fluoroscopy time | standard definition | immediately after the procedure | |
Secondary | Fluoroscopy dose | standard definition | immediately after the procedure | |
Secondary | Contrast volume | standard definition | immediately after the procedure | |
Secondary | Assessing a composite of the number of guidewires, balloons and stents opened or used | standard definition | immediately after the procedure | |
Secondary | Rate lumen gain difference of 20% | measured by IVUS or OCT | 6-9 months after the procedure |
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