First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Biotronik AG
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01960504
First received: October 6, 2013
Last updated: October 23, 2013
Last verified: October 2013

October 6, 2013
October 23, 2013
October 2013
December 2014   (final data collection date for primary outcome measure)
In segment Late Lumen Loss [ Time Frame: 6 months post index procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01960504 on ClinicalTrials.gov Archive Site
  • Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR) [ Time Frame: 1, 6, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • Scaffold thrombosis rate [ Time Frame: 1, 6, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • In-scaffold and in-segment Binary Restenosis Rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • In-scaffold and in-segment Percent Diameter Stenosis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss in segment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss in scaffold [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Procedure success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ] [ Designated as safety issue: Yes ]
    Procedure Success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.
  • Device success [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]

    Device Success is defined as a final residual diameter stenosis of <30% by QCA, using the assigned device only

    • successful delivery of the scaffold to the target lesion site in the coronary artery
    • appropriate scaffold deployment
    • successful removal of the device
    • safe removal of the device in case of deployment failure
Same as current
Not Provided
Not Provided
 
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Coronary Artery Stenosis
Device: Percutaneous Coronary Intervention (DREAMS) stenting
Other Name: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Experimental: Drug Eluting Absorbable Metal Scaffold
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Intervention: Device: Percutaneous Coronary Intervention (DREAMS) stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
121
June 2017
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is > 18 years and < 80 years of age
  • Written subject informed consent available prior to PCI
  • Subjects with stable or unstable angina pectoris or documented silent ischemia
  • Subject eligible for PCI
  • Subject acceptable candidate for coronary artery bypass surgery
  • Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
  • Reference vessel diameter between 2.2-3.8 mm by visual estimation
  • Target lesion length ≤ 21 mm by visual estimation
  • Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100%
  • Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria:

  • Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
  • Evidence of myocardial infarction within 72 hours prior to index procedure
  • Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
  • Unprotected left main coronary artery disease
  • Three-vessel coronary artery disease at time of procedure
  • Thrombus in target vessel
  • Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
  • Planned interventional treatment of any non-target vessel within 30 days post-procedure
  • Subjects on dialysis
  • Planned intervention of the target vessel within 6-month after the index procedure
  • Ostial target lesion (within 5.0 mm of vessel origin)
  • Target lesion involves a side branch >2.0 mm in diameter
  • Documented left ventricular ejection fraction (LVEF) ≤ 30%
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
  • Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
  • Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
  • Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
  • Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
  • Life expectancy less than 1 year
  • Planned surgery or dental surgical procedure within 6 months after index procedure
  • In the investigators opinion subjects will not be able to comply with the follow-up requirements
Both
18 Years to 80 Years
No
Contact: Banu Eyueboglu Seitz, PhD +41 44 864 5872 banu.eyueboglu.seitz@biotronik.com
Contact: Tamara Koch +41 44 864 58 77 tamara.koch@biotronik.com
Denmark,   Switzerland,   Spain,   Brazil,   Singapore,   Belgium,   Germany,   Netherlands
 
NCT01960504
C1209
Yes
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Michael Haude, MD Städtische Kliniken Neuss
Biotronik AG
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP