Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02171065
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2014-06-19
Brief Title:
PROSPECT II PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
A Multicentre Prospective Natural History Study Using Multimodality Imaging in Patients With ACS- PROSPECT II Natural History Study Combined With a Randomized Controlled Intervention Study - PROSPECT ABSORB Randomized Trial
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P2
Brief Summary:
The present study has two components an overall prospective observational study using multimodality imaging PROSPECT II that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities IVUS and NIRS to identify plaques prone to future rupture and clinical events The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold BVS plus GDMT safely increases the minimum lumen area MLA at 24 months compared with GDMT alone
The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB 65 rather than the 70 cutoff identified in the original PROSPECT analysis Stone et al New England Journal of Medicine 20115 to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients Nonetheless in PROSPECT a core laboratory determined PB 65 was also associated with a high 70 rate of major adverse cardiac event MACE during 3-year follow-up a rate which may be reduced with a bioresorbable scaffold
The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB 65 rather than the 70 cutoff identified in the original PROSPECT analysis Stone et al New England Journal of Medicine 20115 to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients Nonetheless in PROSPECT a core laboratory determined PB 65 was also associated with a high 70 rate of major adverse cardiac event MACE during 3-year follow-up a rate which may be reduced with a bioresorbable scaffold
Detailed Description:
Methodology
PROSPECT II Multicenter prospective natural history study of troponin positive patients with acute coronary syndromes ACS examined with angiography and intended for PCI for the initial culprit lesions Prior to PCI all target lesions those lesions for which PCI is planned will be examined if possible by IVUSNIRS After successful PCI of all flow-limiting lesions determined angiographically andor by FFRiFR intended to be treated termed culprit lesions whether responsible for the original ACS or otherwise flow-limiting and requiring PCI for complete revascularization intravascular ultrasound IVUS and intracoronary near infrared spectroscopy NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUSNIRS catheter Clinical and register follow-up will identify all new coronary events the origin of which will be determined by follow-up angiography when clinically indicated These lesions will be identified and compared to the baseline examination at a central angiographic and IVUSNIRS core laboratory and adjudicated to have arisen from either originally treated culprit lesions or untreated non-culprit lesions This will allow determination of the baseline patient-related and lesion-related variables in culprit and non-culprit lesions that increase the risk for future unanticipated cardiovascular events
PROSPECT ABSORB Randomized Trial Patients with angiographically non-obstructive lesions that are not intended to undergo PCI based on the current standard of care and that are site-assessed by IVUS to have plaque burden of 65 which has previously been shown in the first PROSPECT study to identify lesions at high risk of causing future coronary events despite their non-obstructive angiographic appearance will be randomized 11 to treatment with ABSORB BVS guideline directed medical therapy GDMT versus GDMT alone All such randomized patients will undergo repeat angiography and IVUSNIRS after 25 months of follow-up
Patient enrollment and procedure overview
PROSPECT II Patients with a troponin positive ACS within the prior 4 weeks STEMI 12 hours or NSTEMI in whom coronary angiography is planned will be screened and asked to participate in the study After informed consent has been obtained and prior to PCI all target lesions those lesions for which PCI is planned will be examined if possible by IVUSNIRS If the patient is successfully treated with PCI of all intended culprit lesions without major procedural complications all three coronary arteries will be examined with IVUSNIRS The IVUS results will be visible unblinded to the operator but the NIRS data will be blinded The patient will be considered formally enrolled in PROSPECT II only after PCI of all intended target culprit lesions has been successfully completed with no major complications and after the study imaging catheter is passed out of the guide catheter into a coronary artery n approximately 900 patients If a staged procedure is required to achieve revascularization of all intended lesions the patient will not be enrolled until after the staged procedure has been performed without major procedural complications Once enrolled IVUS and NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUSNIRS catheter to assess both the treated culprit lesions and long segments of the untreated coronary tree Patient enrollment and 3-vessel IVUS and NIRS imaging may be performed either in the same procedure during which the culprit PCI lesions are treated or during a subsequent angiographic procedure as long as this occurs within 4 weeks of the initial ACS presentation and after successful and uncomplicated treatment of all target lesions If the imaging catheter passed into a coronary artery for imaging a non-culprit segment of the coronary tree and no non-culprit segment imaging data is obtained eg the catheter fails and a second catheter is not used the patient will be disenrolled discontinued from the study and only be followed up for safety purposes for 30 days
PROSPECT ABSORB Patients in whom one or more lesions are identified with a an angiographically visually estimated diameter stenosis of 70 b a visually estimated reference vessel diameter RVD of 25 - 40 mm c a visually estimated lesion length 50 mm d a site determined IVUS PB 65 and e is located at least 10 mm from a previous stent and at least 10 mm of intervening segment between the previous stent and the non-culprit lesion does not have PB 50 will be enrolled in the PROSPECT ABSORB trial and randomized 11 to treatment with ABSORB BVS GDMT versus GDMT alone n approximately 300 patients 150 patients in each group For patients with multiple qualifying lesions a single lesion will be selected for randomization prior to assignment to BVS GDMT versus GDMT alone
Study follow-up
PROSPECT II Natural History Study
Clinical follow-up
Patients will be followed in the Scandinavian quality registers eg SWEDEHEART Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month 30 days 6 months 180 days 12 months and 24 months assessing MACE and safety parameters MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years Additional phone follow-up to patients may also be performed
PROSPECT ABSORB Randomized Trial
Clinical follow-up
Patients will be followed in the Scandinavian quality registers eg SWEDEHEART Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month 30 days 6 months 180 days 12 months and 24 months MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years with additional phone follow-up subject to Executive Committee approval
Angiographic follow-up
All patients randomized in PROSPECT-ABSORB will undergo routine angiographic and 3-vessel IVUSNIRS follow-up at 25 months ie 1 month after the 24 month telephone follow-up The 25 month angiogram may be performed within a window of between 245 months and 28 months after enrollment
Note 25-month angiographic follow-up will not be required in PROSPECT-ABSORB randomized patients who either a have had scaffold thrombosis or in-scaffold restenosis DS50 as determined by the angiographic core laboratory at any time point prior to 25 months OR b have had a repeat angiogram 12 months after enrollment and in whom IVUSNIRS of the randomized target lesion was performed
PROSPECT II Multicenter prospective natural history study of troponin positive patients with acute coronary syndromes ACS examined with angiography and intended for PCI for the initial culprit lesions Prior to PCI all target lesions those lesions for which PCI is planned will be examined if possible by IVUSNIRS After successful PCI of all flow-limiting lesions determined angiographically andor by FFRiFR intended to be treated termed culprit lesions whether responsible for the original ACS or otherwise flow-limiting and requiring PCI for complete revascularization intravascular ultrasound IVUS and intracoronary near infrared spectroscopy NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUSNIRS catheter Clinical and register follow-up will identify all new coronary events the origin of which will be determined by follow-up angiography when clinically indicated These lesions will be identified and compared to the baseline examination at a central angiographic and IVUSNIRS core laboratory and adjudicated to have arisen from either originally treated culprit lesions or untreated non-culprit lesions This will allow determination of the baseline patient-related and lesion-related variables in culprit and non-culprit lesions that increase the risk for future unanticipated cardiovascular events
PROSPECT ABSORB Randomized Trial Patients with angiographically non-obstructive lesions that are not intended to undergo PCI based on the current standard of care and that are site-assessed by IVUS to have plaque burden of 65 which has previously been shown in the first PROSPECT study to identify lesions at high risk of causing future coronary events despite their non-obstructive angiographic appearance will be randomized 11 to treatment with ABSORB BVS guideline directed medical therapy GDMT versus GDMT alone All such randomized patients will undergo repeat angiography and IVUSNIRS after 25 months of follow-up
Patient enrollment and procedure overview
PROSPECT II Patients with a troponin positive ACS within the prior 4 weeks STEMI 12 hours or NSTEMI in whom coronary angiography is planned will be screened and asked to participate in the study After informed consent has been obtained and prior to PCI all target lesions those lesions for which PCI is planned will be examined if possible by IVUSNIRS If the patient is successfully treated with PCI of all intended culprit lesions without major procedural complications all three coronary arteries will be examined with IVUSNIRS The IVUS results will be visible unblinded to the operator but the NIRS data will be blinded The patient will be considered formally enrolled in PROSPECT II only after PCI of all intended target culprit lesions has been successfully completed with no major complications and after the study imaging catheter is passed out of the guide catheter into a coronary artery n approximately 900 patients If a staged procedure is required to achieve revascularization of all intended lesions the patient will not be enrolled until after the staged procedure has been performed without major procedural complications Once enrolled IVUS and NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUSNIRS catheter to assess both the treated culprit lesions and long segments of the untreated coronary tree Patient enrollment and 3-vessel IVUS and NIRS imaging may be performed either in the same procedure during which the culprit PCI lesions are treated or during a subsequent angiographic procedure as long as this occurs within 4 weeks of the initial ACS presentation and after successful and uncomplicated treatment of all target lesions If the imaging catheter passed into a coronary artery for imaging a non-culprit segment of the coronary tree and no non-culprit segment imaging data is obtained eg the catheter fails and a second catheter is not used the patient will be disenrolled discontinued from the study and only be followed up for safety purposes for 30 days
PROSPECT ABSORB Patients in whom one or more lesions are identified with a an angiographically visually estimated diameter stenosis of 70 b a visually estimated reference vessel diameter RVD of 25 - 40 mm c a visually estimated lesion length 50 mm d a site determined IVUS PB 65 and e is located at least 10 mm from a previous stent and at least 10 mm of intervening segment between the previous stent and the non-culprit lesion does not have PB 50 will be enrolled in the PROSPECT ABSORB trial and randomized 11 to treatment with ABSORB BVS GDMT versus GDMT alone n approximately 300 patients 150 patients in each group For patients with multiple qualifying lesions a single lesion will be selected for randomization prior to assignment to BVS GDMT versus GDMT alone
Study follow-up
PROSPECT II Natural History Study
Clinical follow-up
Patients will be followed in the Scandinavian quality registers eg SWEDEHEART Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month 30 days 6 months 180 days 12 months and 24 months assessing MACE and safety parameters MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years Additional phone follow-up to patients may also be performed
PROSPECT ABSORB Randomized Trial
Clinical follow-up
Patients will be followed in the Scandinavian quality registers eg SWEDEHEART Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month 30 days 6 months 180 days 12 months and 24 months MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years with additional phone follow-up subject to Executive Committee approval
Angiographic follow-up
All patients randomized in PROSPECT-ABSORB will undergo routine angiographic and 3-vessel IVUSNIRS follow-up at 25 months ie 1 month after the 24 month telephone follow-up The 25 month angiogram may be performed within a window of between 245 months and 28 months after enrollment
Note 25-month angiographic follow-up will not be required in PROSPECT-ABSORB randomized patients who either a have had scaffold thrombosis or in-scaffold restenosis DS50 as determined by the angiographic core laboratory at any time point prior to 25 months OR b have had a repeat angiogram 12 months after enrollment and in whom IVUSNIRS of the randomized target lesion was performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None